Tags

Type your tag names separated by a space and hit enter

A randomized placebo-controlled trial of gabapentin for cocaine dependence.
Drug Alcohol Depend. 2006 Feb 28; 81(3):267-74.DA

Abstract

BACKGROUND

In laboratory animals, augmentation of GABA neurotransmission results in inhibition of cocaine self-administration and inhibition of reinstatement to cocaine-seeking behaviors. If parallel effects were observed in humans, GABA-ergic medication should be effective both in the abstinence-induction as well as in the relapse-prevention phase of cocaine dependence treatment. Gabapentin is an anticonvulsant medication that increases human brain GABA levels. We evaluated the safety and efficacy of gabapentin combined with relapse-prevention therapy in the treatment of cocaine-dependent individuals.

DESIGN

The study involved 129 individuals with cocaine dependence. Of the 99 participants, who were randomized into a double-blind trial 88% were males, 66% were minorities and with an average age of 39 years (range 22-58 years). After 2 weeks of placebo lead-in, participants were randomized to receive either gabapentin 3200 mg (1600 mg bid) or placebo for 12 weeks, followed by 2 weeks of placebo lead-out. Prior to randomization, participants were stratified into four groups based on the principal route of cocaine use (smokers versus intranasal users) and the level of cocaine use during the 2 weeks of lead-in (high level versus low level). Throughout the 16 weeks study, participants received weekly individual relapse-prevention therapy. The outcome measures included: days of cocaine use and a binary indicator of abstinence based on urine toxicology test, self-reported cocaine craving and retention in treatment.

RESULTS

Forty-nine percent of randomized patients completed 12 weeks of the trial. Retention did not differ by treatment group but cocaine-smokers dropped out of treatment at a significantly faster rate than intranasal users. For the entire sample, odds of cocaine use over the course of the study did not differ between gabapentin- and placebo-treated individuals. There was a significant difference in the odds of cocaine use between high and low-use groups, with the odds in high-use groups decreasing over time and odds in the low-use groups gradually increasing over the course of the study, such that by the end of the study low and high users were similarly likely to use cocaine. In the low-use group, there was a non-significant trend suggesting that gabapentin-treated subjects had more favorable outcome compared to placebo-treated individuals. There was no treatment effect on abstinence rates, craving or other substance use. Gabapentin at 3200 mg/day was very well tolerated in this group of cocaine-dependent participants.

CONCLUSIONS

When combined with weekly individual relapse-prevention therapy, gabapentin 1600 mg bid was no more effective than placebo in the treatment of cocaine dependence. When reviewed in conjunction with other published studies, gabapentin and other GABA enhancing anticonvulsant medications may deserve further study as relapse-preventive agents in cocaine-dependent individuals who achieve abstinence early in treatment.

Authors+Show Affiliations

Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY, USA. amb107@columbia.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

16169160

Citation

Bisaga, Adam, et al. "A Randomized Placebo-controlled Trial of Gabapentin for Cocaine Dependence." Drug and Alcohol Dependence, vol. 81, no. 3, 2006, pp. 267-74.
Bisaga A, Aharonovich E, Garawi F, et al. A randomized placebo-controlled trial of gabapentin for cocaine dependence. Drug Alcohol Depend. 2006;81(3):267-74.
Bisaga, A., Aharonovich, E., Garawi, F., Levin, F. R., Rubin, E., Raby, W. N., & Nunes, E. V. (2006). A randomized placebo-controlled trial of gabapentin for cocaine dependence. Drug and Alcohol Dependence, 81(3), 267-74.
Bisaga A, et al. A Randomized Placebo-controlled Trial of Gabapentin for Cocaine Dependence. Drug Alcohol Depend. 2006 Feb 28;81(3):267-74. PubMed PMID: 16169160.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized placebo-controlled trial of gabapentin for cocaine dependence. AU - Bisaga,Adam, AU - Aharonovich,Efrat, AU - Garawi,Fatima, AU - Levin,Frances R, AU - Rubin,Eric, AU - Raby,Wilfrid N, AU - Nunes,Edward V, Y1 - 2005/10/05/ PY - 2005/05/23/received PY - 2005/07/25/revised PY - 2005/07/25/accepted PY - 2005/9/20/pubmed PY - 2006/7/13/medline PY - 2005/9/20/entrez SP - 267 EP - 74 JF - Drug and alcohol dependence JO - Drug Alcohol Depend VL - 81 IS - 3 N2 - BACKGROUND: In laboratory animals, augmentation of GABA neurotransmission results in inhibition of cocaine self-administration and inhibition of reinstatement to cocaine-seeking behaviors. If parallel effects were observed in humans, GABA-ergic medication should be effective both in the abstinence-induction as well as in the relapse-prevention phase of cocaine dependence treatment. Gabapentin is an anticonvulsant medication that increases human brain GABA levels. We evaluated the safety and efficacy of gabapentin combined with relapse-prevention therapy in the treatment of cocaine-dependent individuals. DESIGN: The study involved 129 individuals with cocaine dependence. Of the 99 participants, who were randomized into a double-blind trial 88% were males, 66% were minorities and with an average age of 39 years (range 22-58 years). After 2 weeks of placebo lead-in, participants were randomized to receive either gabapentin 3200 mg (1600 mg bid) or placebo for 12 weeks, followed by 2 weeks of placebo lead-out. Prior to randomization, participants were stratified into four groups based on the principal route of cocaine use (smokers versus intranasal users) and the level of cocaine use during the 2 weeks of lead-in (high level versus low level). Throughout the 16 weeks study, participants received weekly individual relapse-prevention therapy. The outcome measures included: days of cocaine use and a binary indicator of abstinence based on urine toxicology test, self-reported cocaine craving and retention in treatment. RESULTS: Forty-nine percent of randomized patients completed 12 weeks of the trial. Retention did not differ by treatment group but cocaine-smokers dropped out of treatment at a significantly faster rate than intranasal users. For the entire sample, odds of cocaine use over the course of the study did not differ between gabapentin- and placebo-treated individuals. There was a significant difference in the odds of cocaine use between high and low-use groups, with the odds in high-use groups decreasing over time and odds in the low-use groups gradually increasing over the course of the study, such that by the end of the study low and high users were similarly likely to use cocaine. In the low-use group, there was a non-significant trend suggesting that gabapentin-treated subjects had more favorable outcome compared to placebo-treated individuals. There was no treatment effect on abstinence rates, craving or other substance use. Gabapentin at 3200 mg/day was very well tolerated in this group of cocaine-dependent participants. CONCLUSIONS: When combined with weekly individual relapse-prevention therapy, gabapentin 1600 mg bid was no more effective than placebo in the treatment of cocaine dependence. When reviewed in conjunction with other published studies, gabapentin and other GABA enhancing anticonvulsant medications may deserve further study as relapse-preventive agents in cocaine-dependent individuals who achieve abstinence early in treatment. SN - 0376-8716 UR - https://www.unboundmedicine.com/medline/citation/16169160/A_randomized_placebo_controlled_trial_of_gabapentin_for_cocaine_dependence_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0376-8716(05)00238-3 DB - PRIME DP - Unbound Medicine ER -