Naltrexone for Bipolar Disorder and Alcohol Dependence

NCT00223275 | Completed Phase 4

• 1 other identifier: PA-03-107
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bipolar Disorder; Alcohol Dependence

Keywords

Bipolar Disorder; Alcohol Dependence; Dual Diagnosis; Naltrexone

Interventions

Naltrexone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UTSouthwestern Medical Center

Dallas, Texas, 75390-8849, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Edson S Brown, MD, PhD

  UT Southwestern Medical Center Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 24, 2011

Record last verified: 2011-05

Locations

US (1)