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| Descriptive Information Fields | |
| Brief Title † | Use of Naltrexone in a Clinical Setting |
| Official Title † | Effectiveness of Naltrexone in a Community Setting |
| 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. |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Open Label, Placebo Control, Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Alcoholism |
| Intervention † | Drug: naltrexone (Revia) |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 300 |
| Start Date † | |
| Completion Date | September 2002 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00000445 |
| Organization ID | NIAAABRA11747 |
| Secondary IDs †† | |
| Study Sponsor † | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Verification Date | July 2003 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |