Status:
COMPLETED
Naltrexone for Bipolar Disorder and Alcohol Dependence
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Bipolar Disorder
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00223275
Start Date
May 1 2005
End Date
September 1 2007
Last Update
May 24 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UTSouthwestern Medical Center
Dallas, Texas, United States, 75390-8849