Gabapentin treatment for alcohol dependence: a randomized clinical trial.
paper
Cited
Public
- Authors
- Mason, Barbara J; Quello, Susan; Goodell, Vivian; Shadan, Farhad; Kyle, Mark; Begovic, Adnan
- Year
- 2014
- Journal
- JAMA internal medicine
- PMID
- 24190578
- DOI
- 10.1001/jamainternmed.2013.11950
- PMCID
- PMC3920987
IMPORTANCE: Approved medications for alcohol dependence are prescribed for less than 9% of US alcoholics. OBJECTIVE: To determine if gabapentin, a widely prescribed generic calcium channel/Ξ³-aminobutyric acid-modulating medication, increases rates of sustained abstinence and no heavy drinking and decreases alcohol-related insomnia, dysphoria, and craving, in a dose-dependent manner. DESIGN, PARTICIPANTS AND SETTING: A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women older than 18 years with current alcohol dependence, conducted from 2004 through 2010 at a single-site, outpatient clinical research facility adjoining a general medical hospital. INTERVENTIONS: Oral gabapentin (dosages of 0 [placebo], 900 mg, or 1800 mg/d) and concomitant manual-guided counseling. MAIN OUTCOMES AND MEASURES: Rates of complete abstinence and no heavy drinking (coprimary) and changes in mood, sleep, and craving (secondary) over the 12-week study. RESULTS Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1%-13.7%) in the placebo group, 11.1% (95% CI, 5.2%-22.2%) in the 900-mg group, and 17.0% (95% CI, 8.9%-30.1%) in the 1800-mg group (P = .04 for linear dose effect; number needed to treat [NNT] = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6%-37.2%) in the placebo group, 29.6% (95% CI, 19.1%-42.8%) in the 900-mg group, and 44.7% (95% CI, 31.4%-58.8%) in the 1800-mg group (P = .02 for linear dose effect; NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F2 = 7.37; P = .001), sleep (F2 = 136; P < .001), and craving (F2 = 3.56; P = .03). There were no serious drug-related adverse events, and terminations owing to adverse events (9 of 150 participants), time in the study (mean [SD], 9.1 [3.8] weeks), and rate of study completion (85 of 150 participants) did not differ among groups. CONCLUSIONS AND RELEVANCE: Gabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia, dysphoria, and craving, with a favorable safety profile. Increased implementation of pharmacological treatment of alcohol dependence in primary care may be a major benefit of gabapentin as a treatment option for alcohol dependence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00391716.
Flow of participants through the trial.
Gabapentin effects on rates of no heavy drinking and complete abstinence during the 12-week study in the intention-to-treat population (N = 150).
Gabapentin effects on number of drinks per week and number of heavy drinking days per week during the 12-week study in the intention-to-treat population (N = 150).
Gabapentin effects on standardized measures of craving, sleep, and mood during the 12-week study in the intention-to-treat population (N = 150).
β Prev
21β32 of 32
| Name | Type |
|---|---|
| 12-week double-blind phase local | cohort |
| 12-week study local | cohort |
| abstinence | phenotype |
| acamprosate | drug |
| Adverse events local | phenotype |
| alcohol | phenotype |
| Alcohol Craving Questionnaire local | phenotype |
| Alcohol Craving Questionnaire-Short Form local | phenotype |
| Alcohol-cued craving local | phenotype |
| alcohol dependence | phenotype |
| Alcohol dependent participants local | cohort |
| Alcoholics Anonymous (AA) local | cohort |
| Alcoholics Anonymous meetings local | cohort |
| alcoholism | phenotype |
| Alcoholism severity local | phenotype |
| Alcohol-related deaths local | phenotype |
| Alcohol-related liver dysfunction local | phenotype |
| Alcohol Use | phenotype |
| Alcohol Use Disorder | phenotype |
| alpha-2d subunit local | drug |
| amygdala | anatomy |
| Beck Depression Inventory II local | phenotype |
| benzodiazepines | drug |
| blood chemistry local | drug |
| cancer | phenotype |
| cannabis dependence | phenotype |
| cardiovascular disease | phenotype |
| cocaine | phenotype |
| Community-dwelling volunteers local | cohort |
| craving | phenotype |
| Daytime dysfunction local | phenotype |
| Detoxification local | phenotype |
| drinking | phenotype |
| Drinking reduction local | phenotype |
| Drinking urges local | phenotype |
| drinks per week | phenotype |
| Drop-outs local | cohort |
| drug dependence | phenotype |
| Drug group local | drug |
| Drug substitution local | phenotype |
| dysphoria | phenotype |
| epilepsy | phenotype |
| ethanol consumption | phenotype |
| Euphoria and speediness local | phenotype |
| extended amygdala | anatomy |
| fatigue | phenotype |
| GABA | phenotype |
| gabapentin | drug |
| gabapentin 1800 mg local | drug |
| gabapentin 1800mg group local | cohort |
| gabapentin 900 mg local | drug |
| gabapentin 900mg group local | cohort |
| GGT local | other |
| GGT local | phenotype |
| headache | phenotype |
| heavy drinking | phenotype |
| High- and middle-income countries local | cohort |
| Illicit drug dependence disorders local | phenotype |
| Individual therapy local | cohort |
| insomnia | phenotype |
| intention-to-treat population local | cohort |
| LabCorp local | cohort |
| Liver cirrhosis | phenotype |
| Manual-guided counseling local | drug |
| marijuana | phenotype |
| medication | drug |
| Medication compliance | phenotype |
| Methadone | drug |
| methamphetamine | drug |
| misuse | phenotype |
| mood disorders | phenotype |
| motivation | phenotype |
| neuropathic pain | phenotype |
| nicotine | drug |
| no heavy drinking local | phenotype |
| No heavy drinking local | phenotype |
| Non-responders | phenotype |
| opiates | drug |
| outpatients | cohort |
| outpatient volunteers local | cohort |
| participants | cohort |
| Pathological alcohol use local | phenotype |
| Pittsburgh Sleep Quality Index local | phenotype |
| placebo group | cohort |
| Primary care physicians local | cohort |
| protracted abstinence | phenotype |
| Psychiatrists | cohort |
| Psychosocial therapies local | drug |
| Randomized volunteers local | cohort |
| relapse | phenotype |
| Responders | phenotype |
| Safety evaluation local | phenotype |
| Self-help groups local | drug |
| sleep | phenotype |
| Sleep disturbance | phenotype |
| somnolence | phenotype |
| standard drink local | drug |
| study completers | cohort |
| study medication | drug |
| subjects | cohort |
| Successful quitting | phenotype |
| Systematic Assessment for Treatment Emergent Events β General Inquiry (SAFTEE-GI) local | drug |
| Tetrahydrocannabinol | drug |
| trauma | phenotype |
| treatment | phenotype |
| treatment group | cohort |
| Treatment-seeking volunteers with alcohol dependence local | cohort |
| United States | cohort |
| urinalysis local | drug |
| vital signs | phenotype |
| voltage-gated calcium channel | drug |
| Week 13 post-treatment local | cohort |
| Week 24 follow-up assessment local | cohort |
| Week 24 post-treatment local | cohort |
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