Naltrexone for Bipolar Disorder and Alcohol Dependence

May 23, 2011 updated by: University of Texas Southwestern Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-8849
        • UTSouthwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  • English or Spanish-speaking
  • Age 18-70
  • Diagnosis of bipolar I or II.
  • Current mood state of depressed or mixed.
  • Alcohol use of at least 5 drinks in the past 7 days.
  • Current diagnosis of alcohol dependence.

EXCLUSION CRITERIA:

  • Bipolar disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar).
  • Lifetime opiate abuse or dependence or any current use (including prescription drugs).
  • Diagnosis of current dependence on substances other than alcohol (participants with only abuse of other substances are included. Dependence on caffeine and/or nicotine is allowed.)
  • Severe or life-threatening medical illness (e.g., hepatic cirrhosis, congestive heart failure, terminal cancer) or labs consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).
  • Pregnant or nursing female
  • High risk for suicide defined as ≥2 suicide attempts in the past 12 months that required medical attention, or current suicidal ideation with plan and intent.
  • Prior therapy with naltrexone and/or allergic reaction to naltrexone.
  • Current therapy with acamprosate or disulfiram.
  • Member of a vulnerable population (Dementia, cognitively impaired, mental retardation, prisoner)
  • Baseline YMRS or HRSD17 scores ≥ 30.
  • AST, ALT, or bilirubin > 3 times upper limit of normal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Edson S Brown, MD, PhD, UT Southwestern Medical Center Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 24, 2011

Last Update Submitted That Met QC Criteria

May 23, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-03-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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