Naltrexone for Bipolar Disorder and Alcohol Dependence

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Ethanol; Naltrexone

Criteria

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.