We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Naltrexone in a Clinical Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000445
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Naltrexone in a Community Setting
Estimated Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000445


Locations
United States, South Carolina
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information

ClinicalTrials.gov Identifier: NCT00000445     History of Changes
Other Study ID Numbers: NIAAABRA11747
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2003

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents