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NCT00000447 · ClinicalTrials.gov registry record · Phase 4
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT00000447: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT00000447 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000447, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.
Interventions
- DRUG naltrexone (Revia)
- DRUG nicotine replacement patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 1998-09 |
| Est. Completion | 2003-05 |
| Phase | Phase 4 |
What the finished NCT00000447 record still lists
NCT00000447 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which naltrexone (Revia) is the first listed.
NCT00000447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000447 about?
NCT00000447 is a clinical study titled "Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)". This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinenc...
What is the current status of trial NCT00000447?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 1998-09. Estimated completion is 2003-05.
What interventions are being tested in trial NCT00000447?
The interventions under investigation include: naltrexone (Revia) (DRUG), nicotine replacement patch (DRUG).
Who is sponsoring clinical trial NCT00000447?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000447's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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