Naltrexone for Bipolar Disorder and Alcohol Dependence

Completed · Phase 4

Conditions studied: Bipolar Disorder, Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT00223275

Run by

University of Texas Southwestern Medical Center

People needed

50

Starts

2005-05-01

Expected to finish

2007-09-01

Last updated by the study team

2011-05-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UTSouthwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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