Behavior and Naltrexone Treatment for Alcoholics

National Institutes of Health (NIH)

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: naltrexone (Revia); Behavioral: cue exposure treatment; Behavioral: cognitive behavioral therapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000449

NIAAAMON7850

Details and patient eligibility

About

The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets criteria for alcohol dependence.

Exclusion criteria

• Current diagnosis of dependence on other substances except nicotine.
• A history of psychosis or current psychotic symptoms.
• Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
• Current use of disulfiram (Antabuse).
• Evidence of significant cerebral, renal, thyroid, or cardiac disease.
• History of opioid abuse in the previous year.
• History of cirrhosis, hepatocellular disease, or elevated bilirubin.
• Females who are pregnant, nursing, or not using a reliable method of birth control.