Psychostimulant drugs for cocaine dependence

Xavier Castells; Ruth Cunill; Clara Pérez‐Mañá; Xavier Vidal; Dolors Capellà

doi:10.1002/14651858.CD007380.pub4

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Figure 1

Study flow diagram.

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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 4

Forest plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Figure 5

Forest plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.2 Sustained cocaine abstinence.

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Figure 6

Forest plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.3 Number of patients who finished the study.

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Figure 7

Funnel plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.1 Cocaine use by means of urine screen.

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Figure 8

Funnel plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.2 Sustained cocaine abstinence.

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Figure 9

Funnel plot of comparison: 1 Psychostimulants vs placebo: primary analysis, outcome: 1.3 Number of patients who finished the study (retention).

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Analysis 1.1

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Analysis 1.2

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 2 Sustained cocaine abstinence.

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Analysis 1.3

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 3 Number of patients who finished the study.

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Analysis 1.4

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 4 Self‐reported cocaine use.

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Analysis 1.5

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 5 Cocaine craving.

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Analysis 1.6

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 6 Patient‐rated CGI severity scale.

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Analysis 1.7

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 7 Investigator‐rated CGI severity scale.

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Analysis 1.8

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 8 Patient‐rated CGI improvement scale.

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Analysis 1.9

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 9 CGI investigator change.

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Analysis 1.10

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 10 CGI investigator improvement: 1 or 2.

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Analysis 1.11

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 11 Depression symptoms severity.

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Analysis 1.12

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 12 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient.

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Analysis 1.13

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 13 Sustained heroin abstinence.

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Analysis 1.14

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 14 ADHD severity.

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Analysis 1.15

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 15 Dropouts due to any adverse events.

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Analysis 1.16

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 16 Dropouts due to cardiovascular adverse events.

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Analysis 1.17

Comparison 1 Psychostimulants vs placebo: primary analysis, Outcome 17 Serious adverse events.

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Analysis 2.1

Comparison 2 Subgroup analysis: type of drug, Outcome 1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Analysis 2.2

Comparison 2 Subgroup analysis: type of drug, Outcome 2 Sustained cocaine abstinence.

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Analysis 2.3

Comparison 2 Subgroup analysis: type of drug, Outcome 3 Number of patients who finished the study.

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Analysis 2.4

Comparison 2 Subgroup analysis: type of drug, Outcome 4 Cocaine craving.

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Analysis 2.5

Comparison 2 Subgroup analysis: type of drug, Outcome 5 Depression symptoms severity.

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Analysis 2.6

Comparison 2 Subgroup analysis: type of drug, Outcome 6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient.

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Analysis 2.7

Comparison 2 Subgroup analysis: type of drug, Outcome 7 Sustained heroin abstinence.

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Analysis 2.8

Comparison 2 Subgroup analysis: type of drug, Outcome 8 ADHD severity.

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Analysis 2.9

Comparison 2 Subgroup analysis: type of drug, Outcome 9 Dropouts due to any adverse events.

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Analysis 2.10

Comparison 2 Subgroup analysis: type of drug, Outcome 10 Dropouts due to cardiovascular adverse events.

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Analysis 2.11

Comparison 2 Subgroup analysis: type of drug, Outcome 11 Serious adverse events.

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Analysis 3.1

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Analysis 3.2

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 2 Sustained cocaine abstinence.

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Analysis 3.3

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 3 Number of patients who finished the study.

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Analysis 3.4

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 4 Cocaine craving.

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Analysis 3.5

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 5 Depressive symptoms severity.

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Analysis 3.6

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient.

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Analysis 3.7

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 7 Sustained heroin abstinence.

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Analysis 3.8

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 8 ADHD severity.

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Analysis 3.9

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 9 Dropouts due to any adverse events.

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Analysis 3.10

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 10 Dropouts due to cardiovascular adverse events.

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Analysis 3.11

Comparison 3 Subgroup analysis: definition of cocaine use disorder, Outcome 11 Serious adverse events.

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Analysis 4.1

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Analysis 4.2

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 2 Sustained cocaine abstinence.

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Analysis 4.3

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 3 Number of patients who finished the study.

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Analysis 4.4

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 4 Cocaine craving.

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Analysis 4.5

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 5 Depressive symptoms severity.

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Analysis 4.6

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient.

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Analysis 4.7

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 7 Sustained heroin abstinence.

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Analysis 4.8

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 8 ADHD severity.

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Analysis 4.9

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 9 Dropouts due to any adverse events.

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Analysis 4.10

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 10 Dropouts due to cardiovascular adverse events.

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Analysis 4.11

Comparison 4 Subgroup analysis: comorbid ADHD as inclusion criterion, Outcome 11 Serious adverse events.

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Analysis 5.1

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient.

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Analysis 5.2

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 2 Sustained cocaine abstinence.

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Analysis 5.3

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 3 Number of patients who finished the study.

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Analysis 5.4

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 4 Cocaine craving.

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Analysis 5.5

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 5 Depression symptoms severity.

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Analysis 5.6

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient.

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Analysis 5.7

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 7 Sustained heroin abstinence.

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Analysis 5.8

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 8 ADHD severity.

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Analysis 5.9

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 9 Dropouts due to any adverse events.

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Analysis 5.10

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 10 Dropouts due to cardiovascular adverse events.

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Analysis 5.11

Comparison 5 Subgroup analysis: Comorbid opioid dependence as inclusion criterion, Outcome 11 Serious adverse events.

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Analysis 6.1

Comparison 6 Psychostimulants vs placebo: sensitivity analyses of the safety measures, Outcome 1 Dropouts due to any adverse events.

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Analysis 6.2

Comparison 6 Psychostimulants vs placebo: sensitivity analyses of the safety measures, Outcome 2 Dropouts due to cardiovascular adverse events.

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Summary of findings for the main comparison. Psychostimulants for cocaine dependence

Psychostimulants for cocaine dependence
Patient or population: people with cocaine dependence Settings: outpatient Intervention: psychostimulants Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Psychostimulants
Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalysis across the study per participant	—	The mean cocaine use assessed by the mean (SD) of the proportion of cocaine‐free urinalysis across the study per participant in the intervention groups was 0.16 standard deviations higher (0.02 lower to 0.33 higher)	—	526 (8 studies)	⊕⊝⊝⊝ Very low^a,b,c	SMD 0.16 (−0.02 to 0.33)
Sustained cocaine abstinence	Study population		RR 1.36 (1.05 to 1.77)	1549 (14 studies)	⊕⊝⊝⊝ Very low^a,b,c,d	—
	164 per 1000	224 per 1000 (173 to 291)
	Moderate
	147 per 1000	200 per 1000 (154 to 260)
Number of participants who finished the study	Study population		RR 1.00 (0.93 to 1.06)	2205 (24 studies)	⊕⊕⊕⊝ Moderate^b	—
	566 per 1000	566 per 1000 (526 to 600)
	Moderate
	542 per 1000	542 per 1000 (504 to 575)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; SMD: standardised mean difference.
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate.
^aAttrition bias was unclear or high for all the included studies. ^bThe pooled effect has been calculated after combining studies investigating a large number of different drugs, at different doses, in participants with relevant clinical differences (e.g. comorbid opioid dependence). ^c95% confidence interval was wide. Any new study could change the results significantly. ^dStatistical heterogeneity was moderate (28%).

Summary of findings for the main comparison. Psychostimulants for cocaine dependence

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Table 1. Criteria for the assessment of the risk of bias in RCT

Item	Judgment	Description
1. Random sequence generation (selection bias)	Low risk	The investigators describe a random component in the sequence generation process such as: random number table; computerised random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation.
	High risk	The investigators describe a non‐random component in the sequence generation process such as: odd or even date of birth; date (or day) of admission; hospital or clinic record number; alternation; judgement of the clinician; results of a laboratory test or a series of tests; availability of the intervention.
	Unclear risk	Insufficient information about the sequence generation process to permit judgement of low or high risk
2. Allocation concealment (selection bias)	Low risk	Investigators enrolling participants could not foresee assignment because 1 of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web‐based, and pharmacy‐controlled, randomisation); sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes.
	High risk	Investigators enrolling participants could possibly foresee assignments because 1 of the following methods was used: open random allocation schedule (e.g. a list of random numbers); assignment envelopes without appropriate safeguards (e.g. if envelopes were unsealed or nonopaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
	Unclear risk	Insufficient information to permit judgement of low or high risk. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement.
3. Blinding of participants and providers (performance bias) Objective outcomes	Low risk	No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
	High risk	No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding
	Unclear risk	Insufficient information to permit judgement of low or high risk
4. Blinding of participants and providers (performance bias) Subjective outcomes	Low risk	Blinding of participants and providers ensured and unlikely that the blinding could have been broken
	High risk	No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding
	Unclear risk	Insufficient information to permit judgement of low or high risk
5. Blinding of outcome assessor (detection bias) Objective outcomes	Low risk	No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken
	High risk	No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; Blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding
	Unclear risk	Insufficient information to permit judgement of low or high risk
6.Blinding of outcome assessor (detection bias) Subjective outcomes	Low risk	Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken
	High risk	No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; Blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding
	Unclear risk	Insufficient information to permit judgement of low or high risk
7. Incomplete outcome data (attrition bias) For all outcomes except retention in treatment	Low risk	No missing outcome data; Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to introduce bias); Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; Missing data have been imputed using appropriate methods; All randomised participants are reported/analysed in the group they were allocated to by randomisation irrespective of non‐adherence and co‐interventions (intention‐to‐treat)
	High risk	Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; 'As‐treated' analysis done with substantial departure of the intervention received from that assigned at randomisation.
	Unclear risk	Insufficient information to permit judgement of low or high risk (e.g. number randomised not stated, no reasons for missing data provided; number of dropouts not reported for each group)
8. Selective reporting (reporting bias)	Low risk	The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way; The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon).
	High risk	Not all of the study’s pre‐specified primary outcomes have been reported; 1 or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre‐specified; 1 or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); 1 or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis; The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
	Unclear risk	Insufficient information to permit judgement of low or high risk
9. Other bias	Low risk	The study appears to be free from other sources of bias.
	High risk	There is at least 1 important risk of bias. For example, the study: Had a potential source of bias related to the specific study design used; Stopped early due to some data‐dependent process (including a formal‐stopping rule); Had extreme baseline imbalance; Has been claimed to have been fraudulent; or Had some other problem.
	Unclear risk	There may be a risk of bias, but there is either: Insufficient information to assess whether an important risk of bias exists; or Insufficient rationale or evidence that an identified problem will introduce bias.

Table 1. Criteria for the assessment of the risk of bias in RCT

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Table 2. Baseline characteristics of the patients included in the clinical trials of the meta‐analysisa

Sample size (N)

2366

Sex

% female

25.3

Age

Mean age (years)

39.6

Ethnicity

% white

% black

% other

39.3

47.6

13.1

Employment status

% currently employed

39.3

Days of cocaine use/month

Range

10.6‐17.8

Length of cocaine use

Range of mean lifetime cocaine use (years)

7.7‐22.4

Route of cocaine use

% intranasal

% intrapulmonary

% intravenous

23.8

60.8

14.7

Comorbidities

% opioid dependence

% alcohol dependence

21.4

10.4

^aBaseline patient characteristics are presented for trials reporting this information. Sex was available for all studies; age for all studies but one; ethnicity, for 22 studies; the presence of opioid and alcohol dependence, for 24 and 19, respectively; lifetime cocaine use, for 17; days of cocaine use in a month, for 15; employment, for 9; and route of cocaine use, for 13.

Table 2. Baseline characteristics of the patients included in the clinical trials of the meta‐analysisa

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Comparison 1. Psychostimulants vs placebo: primary analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient Show forest plot	8	526	Std. Mean Difference (IV, Random, 95% CI)	0.16 [‐0.02, 0.33]

2 Sustained cocaine abstinence Show forest plot	14	1549	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.05, 1.77]

3 Number of patients who finished the study Show forest plot	24	2205	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.06]

4 Self‐reported cocaine use Show forest plot	1	28	Std. Mean Difference (IV, Random, 95% CI)	0.0 [‐0.74, 0.74]

5 Cocaine craving Show forest plot	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]

6 Patient‐rated CGI severity scale Show forest plot	1	300	Std. Mean Difference (IV, Random, 95% CI)	0.28 [0.05, 0.50]

7 Investigator‐rated CGI severity scale Show forest plot	1	300	Std. Mean Difference (IV, Random, 95% CI)	0.07 [‐0.15, 0.30]

8 Patient‐rated CGI improvement scale Show forest plot	1	300	Std. Mean Difference (IV, Random, 95% CI)	0.27 [0.04, 0.50]

9 CGI investigator change Show forest plot	1	300	Std. Mean Difference (IV, Random, 95% CI)	0.0 [‐0.23, 0.23]

10 CGI investigator improvement: 1 or 2 Show forest plot	1	106	Risk Ratio (IV, Random, 95% CI)	0.81 [0.57, 1.15]

11 Depression symptoms severity Show forest plot	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]

12 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient Show forest plot	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]

13 Sustained heroin abstinence Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]

14 ADHD severity Show forest plot	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]

15 Dropouts due to any adverse events Show forest plot	18	1601	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]

16 Dropouts due to cardiovascular adverse events Show forest plot	11	688	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]

17 Serious adverse events Show forest plot	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

Comparison 1. Psychostimulants vs placebo: primary analysis

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Comparison 2. Subgroup analysis: type of drug

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient Show forest plot	8	526	Std. Mean Difference (IV, Random, 95% CI)	0.16 [‐0.02, 0.33]

1.1 Bupropion	2	176	Std. Mean Difference (IV, Random, 95% CI)	0.24 [‐0.06, 0.54]
1.2 Dexamphetamine	2	90	Std. Mean Difference (IV, Random, 95% CI)	0.31 [‐0.13, 0.74]
1.3 Methylphenidate	3	203	Std. Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.36, 0.19]
1.4 Modafinil	1	57	Std. Mean Difference (IV, Random, 95% CI)	0.59 [0.06, 1.12]
2 Sustained cocaine abstinence Show forest plot	14	1549	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.05, 1.77]

2.1 Bupropion	2	176	Risk Ratio (M‐H, Random, 95% CI)	1.63 [1.03, 2.59]
2.2 Dexamphetamine	3	154	Risk Ratio (M‐H, Random, 95% CI)	1.98 [1.12, 3.52]
2.3 Mazindol	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.29, 2.22]
2.4 Methylphenidate	1	106	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.37, 2.13]
2.5 Mixed amphetamine salts	1	126	Risk Ratio (M‐H, Random, 95% CI)	3.63 [1.15, 11.48]
2.6 Modafinil	6	644	Risk Ratio (M‐H, Random, 95% CI)	1.32 [0.85, 2.04]
2.7 Selegiline	1	300	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.24, 1.44]
3 Number of patients who finished the study Show forest plot	24	2205	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.06]

3.1 Bupropion	3	325	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.89, 1.15]
3.2 Dexamphetamine	4	282	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.91, 2.05]
3.3 Mazindol	4	121	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.76, 1.21]
3.4 Methamphetamine	1	82	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.52, 2.11]
3.5 Methylphenidate	3	203	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.68, 1.21]
3.6 Mixed amphetamine salts	1	126	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.90, 1.45]
3.7 Modafinil	7	723	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.89, 1.21]
3.8 Selegiline	1	300	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.76, 1.03]
3.9 Lisdexamfetamine	1	43	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.48, 1.22]
4 Cocaine craving Show forest plot	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]

4.1 Bupropion	2	137	Std. Mean Difference (IV, Random, 95% CI)	0.07 [‐0.30, 0.44]
4.2 Mazindol	2	52	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.81, 0.30]
4.3 Selegiline	1	300	Std. Mean Difference (IV, Random, 95% CI)	0.09 [‐0.14, 0.31]
4.4 Lisdexamfetamine	1	43	Std. Mean Difference (IV, Random, 95% CI)	‐0.73 [‐1.35, ‐0.11]
5 Depression symptoms severity Show forest plot	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]

5.1 Bupropion	1	62	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.54, 0.46]
5.2 Mazindol	1	28	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.87, 0.61]
6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient Show forest plot	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]

6.1 Bupropion	1	105	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.13, 0.71]
6.2 Dexamphetamine	1	62	Std. Mean Difference (IV, Random, 95% CI)	0.31 [‐0.24, 0.85]
7 Sustained heroin abstinence Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]

7.1 Bupropion	1	105	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.78, 3.15]
7.2 Dexamphetamine	1	94	Risk Ratio (M‐H, Random, 95% CI)	1.98 [1.28, 3.04]
8 ADHD severity Show forest plot	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]

8.1 Methylphenidate	2	121	Std. Mean Difference (IV, Random, 95% CI)	‐0.36 [‐1.11, 0.38]
8.2 Mixed amphetamine salts	1	126	Std. Mean Difference (IV, Random, 95% CI)	‐0.55 [‐0.93, ‐0.18]
9 Dropouts due to any adverse events Show forest plot	18	1601	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]

9.1 Bupropion	1	149	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.05, 0.05]
9.2 Dexamphetamine	2	158	Risk Difference (M‐H, Random, 95% CI)	0.12 [‐0.06, 0.30]
9.3 Mazindol	4	121	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.09, 0.07]
9.4 Methamphetamine	1	82	Risk Difference (M‐H, Random, 95% CI)	0.02 [‐0.05, 0.08]
9.5 Methylphenidate	3	216	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.05, 0.03]
9.6 Selegiline	1	300	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.01, 0.01]
9.7 Modafinil	4	406	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.05, 0.02]
9.8 Mixed amphetamine salts	1	126	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.04, 0.04]
9.9 Lisdexamfetamine	1	43	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.09, 0.09]
10 Dropouts due to cardiovascular adverse events Show forest plot	11	688	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]

10.1 Bupropion	1	149	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.03, 0.03]
10.2 Dexamphetamine	1	30	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.12, 0.12]
10.3 Mazindol	3	84	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.07, 0.07]
10.4 Methylphenidate	3	216	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.05, 0.03]
10.5 Modafinil	1	40	Risk Difference (M‐H, Random, 95% CI)	‐0.06 [‐0.19, 0.08]
10.6 Mixed amphetamine salts	1	126	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.04, 0.04]
10.7 Lisdexamfetamine	1	43	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.09, 0.09]
11 Serious adverse events Show forest plot	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

11.1 Mixed amfetamine salts	1	126	Risk Difference (M‐H, Random, 95% CI)	‐0.05 [‐0.12, 0.02]
11.2 Modafinil	4	275	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.08, 0.04]
11.3 Lisdexamfetamine	1	43	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.13, 0.12]

Comparison 2. Subgroup analysis: type of drug

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Comparison 3. Subgroup analysis: definition of cocaine use disorder

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient Show forest plot	8	526	Std. Mean Difference (IV, Random, 95% CI)	0.16 [‐0.02, 0.33]

1.1 Cocaine abuse or dependence	2	176	Std. Mean Difference (IV, Random, 95% CI)	0.24 [‐0.06, 0.54]
1.2 Cocaine dependence	6	350	Std. Mean Difference (IV, Random, 95% CI)	0.14 [‐0.13, 0.40]
2 Sustained cocaine abstinence Show forest plot	14	1549	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.05, 1.77]

2.1 Cocaine abuse or dependence	2	176	Risk Ratio (M‐H, Random, 95% CI)	1.63 [1.03, 2.59]
2.2 Cocaine dependence	12	1373	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.95, 1.81]
3 Number of patients who finished the study Show forest plot	24	2205	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.06]

3.1 Cocaine abuse or dependence	3	200	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.69, 1.24]
3.2 Cocaine dependence	21	2005	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.07]
4 Cocaine craving Show forest plot	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]

4.1 Cocaine abuse or dependence	2	36	Std. Mean Difference (IV, Random, 95% CI)	‐0.53 [‐1.21, 0.14]
4.2 Cocaine dependence	4	496	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.36, 0.26]
5 Depressive symptoms severity Show forest plot	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]

5.1 Cocaine abuse or dependence	1	62	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.54, 0.46]
5.2 Cocaine dependence	1	28	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.87, 0.61]
6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient Show forest plot	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]

6.1 Cocaine abuse or dependence	1	105	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.13, 0.71]
6.2 Cocaine dependence	1	62	Std. Mean Difference (IV, Random, 95% CI)	0.31 [‐0.24, 0.85]
7 Sustained heroin abstinence Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]

7.1 Cocaine abuse or dependence	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]
7.2 Cocaine dependence	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8 ADHD severity Show forest plot	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]

8.1 Cocaine abuse or dependence	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
8.2 Cocaine dependence	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]
9 Dropouts due to any adverse events Show forest plot	18	1601	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]

9.1 Cocaine abuse or dependence	1	24	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.15, 0.15]
9.2 Cocaine dependence	17	1577	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]
10 Dropouts due to cardiovascular adverse events Show forest plot	10	645	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]

10.1 Cocaine abuse or dependence	1	24	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.15, 0.15]
10.2 Cocaine dependence	9	621	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]
11 Serious adverse events Show forest plot	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

11.1 Cocaine abuse and dependence	0	0	Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
11.2 Cocaine dependence	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

Comparison 3. Subgroup analysis: definition of cocaine use disorder

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Comparison 4. Subgroup analysis: comorbid ADHD as inclusion criterion

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient Show forest plot	8	526	Std. Mean Difference (IV, Random, 95% CI)	0.16 [‐0.02, 0.33]

1.1 With comorbid ADHD	2	154	Std. Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.33, 0.30]
1.2 Without comorbid ADHD	6	372	Std. Mean Difference (IV, Random, 95% CI)	0.23 [0.02, 0.44]
2 Sustained cocaine abstinence Show forest plot	14	1549	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.05, 1.77]

2.1 With comorbid ADHD	2	232	Risk Ratio (M‐H, Random, 95% CI)	1.71 [0.42, 6.98]
2.2 Without comorbid ADHD	12	1317	Risk Ratio (M‐H, Random, 95% CI)	1.34 [1.03, 1.74]
3 Number of patients who finished the study Show forest plot	24	2205	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.06]

3.1 With comorbid ADHD	3	280	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.87, 1.28]
3.2 Without comorbid ADHD	21	1925	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.92, 1.06]
4 Cocaine craving Show forest plot	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]

4.1 With comorbid ADHD	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Without comorbid ADHD	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]
5 Depressive symptoms severity Show forest plot	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]

5.1 With comorbid ADHD	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Without comorbid ADHD	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]
6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient Show forest plot	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]

6.1 With comorbid ADHD	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
6.2 Without comorbid ADHD	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]
7 Sustained heroin abstinence Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]

7.1 With comorbid ADHD	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
7.2 Withou comorbid ADHD	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]
8 ADHD severity Show forest plot	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]

8.1 With comorbid ADHD	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]
8.2 Without comorbid ADHD	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
9 Dropouts due to any adverse events Show forest plot	18	1601	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]

9.1 With comorbid ADHD	3	280	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.03, 0.03]
9.2 Without comorbid ADHD	15	1321	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]
10 Dropouts due to cardiovascular adverse events Show forest plot	11	688	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]

10.1 With comorbid ADHD	3	280	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.03, 0.02]
10.2 Without comorbid ADHD	8	408	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.02]
11 Serious adverse events Show forest plot	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

11.1 With ADHD	0	0	Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
11.2 Without ADHD	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

Comparison 4. Subgroup analysis: comorbid ADHD as inclusion criterion

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Comparison 5. Subgroup analysis: Comorbid opioid dependence as inclusion criterion

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cocaine use assessed by the mean (SD) proportion of cocaine‐free urinalyses across the study per patient Show forest plot	8	526	Std. Mean Difference (IV, Random, 95% CI)	0.16 [‐0.02, 0.33]

1.1 With comorbid opioid dependence	2	166	Std. Mean Difference (IV, Random, 95% CI)	0.26 [‐0.05, 0.58]
1.2 Without comorbid opioid dependence	6	360	Std. Mean Difference (IV, Random, 95% CI)	0.13 [‐0.13, 0.38]
2 Sustained cocaine abstinence Show forest plot	14	1549	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.05, 1.77]

2.1 With comorbid opioid dependence	2	200	Risk Ratio (M‐H, Random, 95% CI)	1.85 [1.23, 2.79]
2.2 Without comorbid opioid dependence	12	1349	Risk Ratio (M‐H, Random, 95% CI)	1.22 [0.91, 1.66]
3 Number of patients who finished the study Show forest plot	24	2205	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.93, 1.06]

3.1 With comorbid opioid dependence	5	403	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.91, 1.14]
3.2 Without comorbid opioid dependence	19	1802	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.91, 1.07]
4 Cocaine craving Show forest plot	6	532	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.40, 0.17]

4.1 With comorbid opioid dependence	1	125	Std. Mean Difference (IV, Random, 95% CI)	0.13 [‐0.22, 0.48]
4.2 Without comorbid opioid dependence	5	407	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.65, 0.14]
5 Depression symptoms severity Show forest plot	2	90	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.48, 0.34]

5.1 With comorbid opioid dependence	1	62	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.54, 0.46]
5.2 Without comorbid opioid dependence	1	28	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.87, 0.61]
6 Heroin use assessed by the mean (SD) proportion of heroin‐free urinalyses across the study per patient Show forest plot	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]

6.1 With comorbid opioid dependence	2	167	Std. Mean Difference (IV, Random, 95% CI)	0.29 [‐0.02, 0.61]
6.2 Without comorbid opioid dependence	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
7 Sustained heroin abstinence Show forest plot	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]

7.1 With comorbid opioid dependence	2	199	Risk Ratio (M‐H, Random, 95% CI)	1.72 [1.15, 2.56]
7.2 Without comorbid opioid dependence	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8 ADHD severity Show forest plot	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]

8.1 With comorbid opioid dependence	0	0	Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
8.2 Without comorbid opioid dependence	3	247	Std. Mean Difference (IV, Random, 95% CI)	‐0.41 [‐0.83, 0.01]
9 Dropouts due to any adverse events Show forest plot	18	1601	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]

9.1 With comorbid opioid dependence	4	265	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.04, 0.05]
9.2 Without comorbid opioid dependence	14	1336	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]
10 Dropouts due to cardiovascular adverse events Show forest plot	11	688	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.02, 0.01]

10.1 With comorbid opioid dependence	3	228	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.02, 0.02]
10.2 Without comorbid opioid dependence	8	460	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.03, 0.02]
11 Serious adverse events Show forest plot	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

11.1 With comorbid opioid dependence	0	0	Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
11.2 Without comorbid opioid dependence	6	444	Risk Difference (M‐H, Random, 95% CI)	‐0.02 [‐0.06, 0.01]

Comparison 5. Subgroup analysis: Comorbid opioid dependence as inclusion criterion

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Comparison 6. Psychostimulants vs placebo: sensitivity analyses of the safety measures

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dropouts due to any adverse events Show forest plot	18	1601	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.60, 2.02]

2 Dropouts due to cardiovascular adverse events Show forest plot	11	688	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.09, 2.70]

Comparison 6. Psychostimulants vs placebo: sensitivity analyses of the safety measures

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