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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.

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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)

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Assessing Validity of an Article about Therapy

  • Are the results valid?

  • What are the results?

  • How can I apply the results to patient care?

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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?

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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?

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Were patients randomized?

  • Yes.

    • Patients were randomized using a computer-generated randomization code.

    • Patients were randomized in a 1:1:1 ratio.

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Was randomization concealed?

  • Yes.

    • The randomization code was kept by the study pharmacist who administered the medication.

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Were patients analyzed in the groups to which they were randomized?

  • Yes.

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Were the patients in the treatment and control groups similar?

  • Yes.

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Were patients aware of group allocation?

  • No.

    • Patients were blinded to group allocation.

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Were clinicians aware of group allocation?

  • No.

    • Only the study pharmacist was aware of group allocation. Other researchers or clinicians were not.

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Were outcome assessors aware of group allocation?

  • No.

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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

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What Are the Results?

  • How large was the treatment effect?

  • How precise was the estimate of the treatment effect?

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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%)

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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?

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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.

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Were all clinically important outcomes considered?

  • Yes.

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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.

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