Anticonvulsants for cocaine dependence

Silvia Minozzi; Michela Cinquini; Laura Amato; Marina Davoli; Michael F Farrell; Pier Paolo Pani; Simona Vecchi

doi:10.1002/14651858.CD006754.pub4

Cochrane Database of Systematic Reviews

Anticonvulsants for cocaine dependence

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DOI:

https://doi.org/10.1002/14651858.CD006754.pub4 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

17 abril 2015see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Alcohol y drogas

Copyright:

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Silvia Minozzi

Correspondencia a: Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

[email protected]
Michela Cinquini

Centro Cochrane Italiano, Mario Negri, MILANO, Italy
Laura Amato

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy
Marina Davoli

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy
Michael F Farrell

National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia
Pier Paolo Pani

Social‐Health Division, Health District 8 (ASL 8) Cagliari, Cagliari, Italy
Simona Vecchi

Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

Contributions of authors

Amato wrote the background, Pani and Minozzi helped with suggestions and comments and Marina Davoli supervised. Amato inspected the search hits by reading titles and abstracts. Each potentially relevant study identified in the search was obtained in full text and assessed for inclusion independently by two review authors (Minozzi, Amato). Doubts were resolved by discussion between all review authors. Minozzi assessed the quality of the included studies, and Amato and Minozzi extracted data. The other review authors are the former authors of a review of carbamazepine for cocaine dependence, which now is joined with this review.

For the update, Minozzi and Cinquini inspected the search hits by reading titles and abstracts. Each potentially relevant study identified in the search was obtained in full text and assessed for inclusion independently by two review authors (Minozzi, Cinquinii). Pani supervised. Minozzi and Cinquini assessed risk of bias and extracted data. Pani and Amato supervised and contributed to the discussion and the conclusions.

Sources of support

Internal sources

Department of Epidemiology, ASL RM E, Italy.

External sources

No sources of support supplied

Declarations of interest

None.

Acknowledgements

We would like to thank Zuzana Mitrova for helping with search strategies and for facilitating the editorial process, and Professor Robert Ali, who is the contact editor for this review.

Version history

Published

Title

Stage

Authors

Version

2015 Apr 17

Anticonvulsants for cocaine dependence

Review

Silvia Minozzi, Michela Cinquini, Laura Amato, Marina Davoli, Michael F Farrell, Pier Paolo Pani, Simona Vecchi

https://doi.org/10.1002/14651858.CD006754.pub4

2015 Mar 03

Anticonvulsants for cocaine dependence

Review

Silvia Minozzi, Laura Amato, Marina Davoli, Michael F Farrell, Anelise ARL Lima Reisser, Pier Paolo Pani, Mauricio Silva de Lima, Bernardo GO Soares, Simona Vecchi

https://doi.org/10.1002/14651858.CD006754.pub3

2008 Apr 23

Anticonvulsants for cocaine dependence

Review

Silvia Minozzi, Laura Amato, Marina Davoli, Michael F Farrell, Anelise ARL Lima Reisser, Pier Paolo Pani, Mauricio Silva de Lima, Bernardo GO Soares, Simona Vecchi

https://doi.org/10.1002/14651858.CD006754.pub2

2007 Oct 17

Anticonvulsants for cocaine dependence

Protocol

M Minozzi, Laura Amato, Pier Paolo Pani, Simona Vecchi, Marina Davoli, Silvia Minozzi

https://doi.org/10.1002/14651858.CD006754

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

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Figure 2

Study flow diagram of the updated version.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Any anticonvulsant versus placebo, Outcome 1 Dropout.

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Analysis 1.2

Comparison 1 Any anticonvulsant versus placebo, Outcome 2 Use of cocaine (self reported or objective).

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Analysis 1.3

Comparison 1 Any anticonvulsant versus placebo, Outcome 3 Side effect.

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Analysis 1.4

Comparison 1 Any anticonvulsant versus placebo, Outcome 4 Craving.

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Analysis 1.5

Comparison 1 Any anticonvulsant versus placebo, Outcome 5 Severity of dependence (ASI).

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Analysis 1.6

Comparison 1 Any anticonvulsant versus placebo, Outcome 6 Severity of dependence (CGI‐O).

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Analysis 1.7

Comparison 1 Any anticonvulsant versus placebo, Outcome 7 Depression (HAM‐D).

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Analysis 1.8

Comparison 1 Any anticonvulsant versus placebo, Outcome 8 Anxiety (HAM‐A).

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Analysis 1.9

Comparison 1 Any anticonvulsant versus placebo, Outcome 9 Compliance.

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Analysis 1.10

Comparison 1 Any anticonvulsant versus placebo, Outcome 10 Compliance.

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Analysis 2.1

Comparison 2 Single anticonvulsant versus placebo, Outcome 1 Dropout.

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Analysis 2.2

Comparison 2 Single anticonvulsant versus placebo, Outcome 2 Use of cocaine (self reported or objective).

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Analysis 2.3

Comparison 2 Single anticonvulsant versus placebo, Outcome 3 Side effects.

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Analysis 3.1

Comparison 3 Anticonvulsant (carbamazepine) vs antidepressant (desipramine), Outcome 1 Dropout.

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Summary of findings for the main comparison. Any anticonvulsant versus placebo for cocaine dependence

Any anticonvulsant versus placebo for cocaine dependence
Patient or population: patients with cocaine dependence Settings: outpatients Intervention: any anticonvulsant versus placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Any anticonvulsant versus placebo
Dropout Number of participants who did not complete the treatment Follow‐up: mean 11.8 weeks¹	45 per 100	42 per 100 (38 to 47)	RR 0.95 (0.86 to 1.05)	1695 (17 studies²)	⊕⊕⊕⊝ Moderate^3,4
Use of cocaine (self reported or objective) Number of participants who reported the use of cocaine during treatment, and/or number of participants with urine samples positive for cocaine Follow‐up: mean 11.8 weeks¹	77 per 100	71 per 100 (65 to 79)	RR 0.92 (0.84 to 1.02)	867 (9 studies⁵)	⊕⊕⊕⊝ Moderate^6,7
Side effect Number of participants reporting at least 1 side effect and types of side effects experienced during treatment Follow‐up: mean 11.8 weeks¹	46 per 100	65 per 100 (47 to 88)	RR 1.39 (1.01 to 1.9)	775 (8 studies)	⊕⊕⊝⊝ Low^8,9
Craving (BSCS) Measured by validated scales (e.g. Brief Substance Craving Scale (BSCS)) Follow‐up: mean 11.8 weeks¹		The mean craving (bscs) in the intervention groups was 0.25 standard deviations lower (0.59 lower to 0.09 higher)		428 (7 studies¹¹)	⊕⊕⊝⊝ Low^11,12,13
The basis for the assumed risk* (e.g. 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.
GRADE (Grades of Recommendation, Assessment, Development and Evaluation) 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.
¹ Range 8 ‐ 24 weeks ² 20 treatment arms ³ In the Cornish 1995, Halikas 1997 arm a, Halikas 1997 arm b;Nuijten 2014, Umbricht 2014 studies an adequate sequence generation method was described and judged at low risk of selection bias. In the other 17 studies the method was not reported (unclear risk of bias). In five studies (Brodie 2009, Cornish 1995, Gonzalez 2007 arm a, Gonzalez 2007 arm b, Kranzler 1995, Umbricht 2014) an adequate method for allocation concealment was judged at low risk of selection bias. In all the other studies the method for allocation concealment was not reported (unclear risk of bias). Campbell 1994 arm was judged at high risk of selective reporting bias because results for drop out were not reported. ⁴ All the seventeen included studies were conducted in the USA ⁵ 11 treatment arm ⁶ In the Cornish 1995, Halikas 1997 arm a, Halikas 1997 arm b;Nuijten 2014 studies an adequate sequence generation method was described and judged at low risk of selection bias. In the other studies the method was not reported (unclear risk of bias). In three studies (Brodie 2009, Cornish 1995, Gonzalez 2007 arm a, Gonzalez 2007 arm b) an adequate method for allocation concealment was judged at low risk of selection bias. In all the other studies the method for allocation concealment was not reported (unclear risk of bias). Nuijten 2014 were judged at high risk of performance bias and at unclear risk of detection bias All the other studies were judged at low risk of performance and detection bias. Cornish 1995, Halikas 1997 arm a, Halikas 1997 arm b, Kranzler 1995, Nuijten 2014 were judged at high risk of attrition bias. ⁷ I‐squared 30% ⁸ In the Brown 2012, Cornish 1995 and Nuijten 2014 studies an adequate sequence generation method was described and judged at low risk of selection bias. In the other studies the method was not reported (unclear risk of bias).One study was judged at high of bias ( Brown 2012) for allocation concealment. All the studies were judged at low risk of performance and detection bias. Brown 2012, Cornish 1995, Crosby 1996, Kranzler 1995, Nuijten 2014) were judged at high risk of attrition bias. All the other studies performed the analysis on the intention to treat basis or did not have withdrawn from the study. ⁹ I‐squared 81% ¹⁰ Eight treatment arms ¹¹In the Nuijten 2014 studies an adequate sequence generation method was described and judged at low risk of selection bias. In the other studies the method was not reported (unclear risk of bias). In all the studies the method for allocation concealment was not reported (unclear risk of bias). Berger 2005 arm a, Berger 2005 arm b and Nuijten 2014 were judged at high risk of performance bias and at unclear risk of detection bias. Winhusen 2005 was judged at high risk both for performance and detection bias. Crosby 1996 and Nuijten 2014 were judged at high risk of attrition bias. ¹²I‐squared 63% ¹³ All the seven included studies were conducted in the USA

Summary of findings for the main comparison. Any anticonvulsant versus placebo for cocaine dependence

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Comparison 1. Any anticonvulsant versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dropout Show forest plot	20	1695	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.86, 1.05]

2 Use of cocaine (self reported or objective) Show forest plot	11	867	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.84, 1.02]

3 Side effect Show forest plot	8	775	Risk Ratio (M‐H, Random, 95% CI)	1.39 [1.01, 1.90]

3.1 New subgroup	8	775	Risk Ratio (M‐H, Random, 95% CI)	1.39 [1.01, 1.90]
4 Craving Show forest plot	8	428	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.59, 0.09]

5 Severity of dependence (ASI) Show forest plot	6	290	Mean Difference (IV, Random, 95% CI)	0.03 [‐0.02, 0.08]

6 Severity of dependence (CGI‐O) Show forest plot	5	277	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.42, 0.20]

7 Depression (HAM‐D) Show forest plot	3	80	Mean Difference (IV, Random, 95% CI)	1.80 [‐0.59, 4.19]

8 Anxiety (HAM‐A) Show forest plot	3	78	Mean Difference (IV, Random, 95% CI)	1.79 [‐1.02, 4.60]

9 Compliance Show forest plot	6	343	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.93, 1.08]

10 Compliance Show forest plot	5	426	Mean Difference (IV, Random, 95% CI)	1.42 [‐4.80, 7.64]

Comparison 1. Any anticonvulsant versus placebo

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Comparison 2. Single anticonvulsant versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dropout Show forest plot	19		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Carbamazepine vs placebo	6	464	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.13]
1.2 Tiagabine vs placebo	3	213	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.56, 1.82]
1.3 Gabapentin vs placebo	2	62	Risk Ratio (M‐H, Random, 95% CI)	2.78 [0.67, 11.61]
1.4 Phenytoin vs placebo	1	44	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.65, 1.35]
1.5 Lamotrigine vs placebo	1	23	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.11, 10.04]
1.6 Topiramate vs placebo	4	557	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.73, 1.16]
1.7 Vigabatrin vs placebo	2	289	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.53, 1.02]
2 Use of cocaine (self reported or objective) Show forest plot	12		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Carbamazepine vs placebo	4	214	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.70, 1.28]
2.2 Tiagabine vs placebo	1	50	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.61, 1.30]
2.3 Gabapentin vs placebo	2	146	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.87, 1.31]
2.4 Phenytoin vs placebo	1	12	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.05, 2.37]
2.5 Topiramate vs placebo	2	210	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.48, 2.98]
2.6 Vigabatrin vs placebo	2	289	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.69, 1.13]
3 Side effects Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Carbamazepine vs placebo	2	122	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.52, 2.86]
3.2 Tiagabine vs placebo	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 Gabapentin vs placebo	1	95	Risk Ratio (M‐H, Random, 95% CI)	2.94 [0.62, 13.83]
3.4 Phenytoin vs placebo	1	44	Risk Ratio (M‐H, Random, 95% CI)	1.65 [0.83, 3.29]
3.5 Topiramate vs placebo	2	216	Risk Ratio (M‐H, Random, 95% CI)	2.42 [0.27, 21.87]
3.6 Vigabatrin vs placebo	1	186	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.88, 1.08]

Comparison 2. Single anticonvulsant versus placebo

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Comparison 3. Anticonvulsant (carbamazepine) vs antidepressant (desipramine)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dropout Show forest plot	1	96	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.86, 1.53]

Comparison 3. Anticonvulsant (carbamazepine) vs antidepressant (desipramine)

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Anticonvulsants for cocaine dependence

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