Naltrexone for Bipolar Disorder and Alcohol Dependence
Condition: Bipolar Disorder; Alcohol Dependence
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The abuse of alcohol is especially common in people with bipolar disorder. However, very
      little is known about how to treat people with both bipolar disorder and alcohol
      abuse/dependence. The purpose of this research is to determine whether naltrexone add-on
      therapy is associated with a greater reduction in alcohol use and alcohol craving than with
      placebo (an inactive substance) therapy.
    

Detailed description: 
      A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of naltrexone
      will be conducted in 50 English- or Spanish-speaking outpatients with bipolar I disorder or
      II disorder and current alcohol dependence. At the baseline appointment, informed consent
      will be obtained, and assessment procedures, including a review of inclusion and exclusion
      criteria, will be performed. The SCID (Structured Clinical Interview for DMS-IV Axis I
      Disorders will be performed to establish the diagnoses of bipolar I or II disorder and
      alcohol dependence. A psychiatrist will confirm the SCID diagnoses obtained by the RA.
      Eligible participants will then be given the Hamilton Rating Scale for Depression 17-item
      version (HRSD17), Inventory of Depressive Symptomatology-Self-Report 30-item version
      (IDS-SR30), Young Mania Rating Scale (YMRS), Penn Alcohol Craving Scale (PACS), Addiction
      Severity Index (ASI), Psychobiology of Recovery in Depression III Somatic Symptom Scale
      (PRD-III), and a urine drug screen. Recent alcohol use (and if present other substance use)
      will be assessed using the Timeline Followback (TLFB) method, with a drink defined as 13.6g
      of absolute alcohol (approximately 12 oz (341 mL) of beer, 5 oz of wine, 3 oz of fortified
      wine, or 1.5 oz of 80 proof liquor). Length of problem alcohol use will be assessed by
      asking, "When did alcohol first start causing you problems?" Blood will be drawn for routine
      laboratory analyses including a complete blood count (CBC) and SMA-20 (includes a liver panel
      with GGT, AST, ALT, Billirubin) at baseline (week 0) and completion (week 12). Blood will
      also be drawn at weeks 4 and 8 for repeat testing of GGT levels. A physical examination will
      be performed at baseline. Women of childbearing potential will receive a urine pregnancy test
      and will be counseled about effective contraceptive methods. A psychiatrist will assess the
      participants at baseline and weekly follow-up visits, and will participate in the informed
      consent process. Study medication will be given at a second appointment after results of the
      liver function tests have been received (generally 1-2 days after the first appointment). At
      each weekly assessment the HRSD17, IDS-R30, YMRS, an assessment of alcohol use in the past
      week, and a urine drug screen will again be obtained. Urine drug screen will be obtained only
      from the newly enrolled subjects. We will not obtain urine drug screens from subjects who are
      already active in the study. In addition, all participants will receive a total of 16
      one-hour/week sessions of manual-driven CBT specifically designed for persons with bipolar
      disorder and substance abuse, provided by a bilingual psychologist with experience in CBT.
      Patients will discontinue study medication at week 12, but continue their CBT therapy until
      week 16. Pill counts will be conducted at each weekly assessment visit. In addition, during
      weekly assessments, participants will be asked about adherence with other psychotropic
      medications using a modified version of an assessment developed by Weiss et al., and the
      estimated percent of prescribed medication actually taken will be recorded.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder; Alcohol Dependence; Dual Diagnosis; Naltrexone