Use of Naltrexone in a Clinical Setting

Alcoholism Clinical Trial

Official title:

Effectiveness of Naltrexone in a Community Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000445
• Other study ID #: NIAAABRA11747
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: September 2002

Study information

• Verified date: July 2003
• 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

This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meets criteria for alcohol dependence (within the past 3 months).

• Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.

• Must be able to provide an informed consent.

• Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.

• Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.

Exclusion Criteria:

• Meets criteria for opiate dependence.

• Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.

• Hepatocellular disease.

• Women who are pregnant, nursing, or not practicing an effective means of birth control.

• Currently being prescribed naltrexone.

• Known sensitivity or allergy to naltrexone.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Locations

Country	Name	City	State
United States	Center for Drug and Alcohol Programs, Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

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

Country where clinical trial is conducted

United States,