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This study evaluates the effects of gabapentin on patients with alcohol dependence, investigating its ability to enhance rates of sustained abstinence and reduce heavy drinking. Conducted as a 12-week, double-blind, placebo-controlled trial involving 150 adults, participants were assigned to one of three groups receiving different doses of gabapentin. Results indicated significant increases in abstinence rates and reductions in heavy drinking among those receiving gabapentin, particularly at higher doses. This research highlights the potential of gabapentin as a treatment for alcohol use disorders.
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Journal Club Alcohol, Other Drugs, and Health: Current Evidence March–April 2014
Featured Article Gabapentin Can Decrease Heavy Drinking and Increase Abstinence for Patients with Alcohol Dependence Mason BJ, et al. JAMA Intern Med. 2014;174(1):70–77.
Study Objective • To determine whether gabapentin can increase rates of sustained abstinence and decrease rates of heavy drinking. www.aodhealth.org
Study Design • A 12-week, double-blind, placebo-controlled randomized dose-ranging trial comparing three groups (N = 150 adults with current alcohol dependence). All groups received counseling. • The three groups received: • Gabapentin 900 mg/day • Gabapentin 1800 mg/day • Gabapentin 0 mg/day (control) www.aodhealth.org
Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org
Are the Results Valid? • Were patients randomized? • Was randomization concealed? • Were patients analyzed in the groups to which they were randomized? • Were patients in the treatment and control groups similar with respect to known prognostic variables? www.aodhealth.org
Are the Results Valid?(cont‘d) • Were patients aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www.aodhealth.org
Were patients randomized? • Yes. • Patients were randomized using a computer-generated randomization code. • Patients were randomized in a 1:1:1 ratio. www.aodhealth.org
Was randomization concealed? • Yes. • The randomization code was kept by the study pharmacist who administered the medication. www.aodhealth.org
Were patients analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org
Were the patients in the treatment and control groups similar? • Yes. www.aodhealth.org
Were patients aware of group allocation? • No. • Patients were blinded to group allocation. www.aodhealth.org
Were clinicians aware of group allocation? • No. • Only the study pharmacist was aware of group allocation. Other researchers or clinicians were not. www.aodhealth.org
Were outcome assessors aware of group allocation? • No. www.aodhealth.org
Was follow-up complete? • No. • The trial was 12 weeks long and patients were administered medication weekly. • Number of patients who provided 12-week data for analysis: • Gabapentin 900 mg group: 27 of 54 initially enrolled • Gabapentin 1800 mg group: 28 of 47 initially enrolled • Control group: 30 of 49 initially enrolled www.aodhealth.org
What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org
How large was the treatment effect? • Gabapentin had a significant linear dose effect in increasing rates of abstinence (P = 0.04). • The rate of 12-week abstinence was: • Gabapentin 900 mg group: 11.1% (95% CI, 5.2%–22.2%) • Gabapentin 1800 mg group: 17% (95% CI, 8.9%–30.1%; NNT = 8; OR = 4.8) • Control: 4.1% (95% CI, 1.1%–13.7%) • The rate of no heavy drinking at 12 weeks was: • Gabapentin 900 mg group: 29.6% (95% CI, 19.1%–42.8%) • Gabapentin 1800 mg group: 44.7% (95% CI, 31.4%–58.8%; NNT = 5; OR = 2.8) • Control: 22.5% (95% CI, 13.6%–37.2%) www.aodhealth.org 17
How Can I Apply the Results to Patient Care? • Were the study patients similar to the patients in my practice? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www.aodhealth.org
Were the study patients similar to those in my practice? • The patients were treatment-seeking adult volunteers. • All were people with current DSM-IV alcoholdependence; the majority had moderate dependence. • They were excluded if urine toxicology screens revealed the use of any other substances besides alcohol or nicotine. • They could not have significant medical or psychiatric disorders. www.aodhealth.org
Were all clinically important outcomes considered? • Yes. www.aodhealth.org
Are the likely treatment benefits worth the potential harm and costs? • Possibly. • There were no differences in the rate of termination due to adverse events by study arm. Costs were not considered. • Due to the loss to follow-up, further studies into acceptability and efficacy of gabapentin for treating alcohol use disorders are needed. • Results may not be generalizable since it was a single-site study. • The overlapping confidence intervals across the study groups suggest that widespread use of the treatment for dependence should await a larger effectiveness trial. www.aodhealth.org
