Behavior and Naltrexone Treatment for Alcoholics

Alcoholism Clinical Trial

Official title:

Coping, Exposure, and Naltrexone Treatment With Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000449
• Other study ID #: NIAAAMON7850
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: March 2000

Study information

• Verified date: August 2002
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Behavioral:
• cognitive behavioral therapy

• cue exposure treatment

Locations

Country	Name	City	State
United States	Brown University, Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,