Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

NIAAABRA11747


NCT ID:

NCT00000445


Secondary ID:


Study Acronym:


Brief Title:

Use of Naltrexone in a Clinical Setting


Official Title:

Effectiveness of Naltrexone in a Community Setting


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Study Dates

Completion Date:September 2002
Verification Date:July 2003
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:naltrexone (Revia)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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