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NCT00167232 · ClinicalTrials.gov registry record · Phase 3
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
NCT00167232: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT00167232 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 164 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00167232, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. However, the medication was not approved as yet at the dosage we will use in this study. The dosage we will use for the study (150 mg), is greater than the recommended dosage from the Physician's Desk Reference (50mg). Unlike other medicines (like Antabuse) useful in the treatment of alcohol dependence, naltrexone will not make you sick if you drink alcohol. Rather, people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them. This study is being conducted because the medication (Naltrexone) has not been well studied in people with both alcohol and cocaine dependence, so it is still investigational. We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy, this may lead to reduced cocaine use. We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use. One type of psychotherapy is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine and/or alcohol use. The other type of psychotherapy we will use focuses on strengthening motivation to recover from cocaine and/or alcohol use, and on developing techniques to handle possible barriers to recovery. We seek to enroll 300 patients in the study.
Interventions
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 1998-01 |
| Est. Completion | 2003-07 |
| Phase | Phase 3 |
What the finished NCT00167232 record still lists
NCT00167232 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Naltrexone is the first listed.
NCT00167232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00167232 about?
NCT00167232 is a clinical study titled "Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence". The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse, as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence. Naltrexone is approved by the Food and Drug Administration (FDA) for the treatment of al...
What is the current status of trial NCT00167232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 1998-01. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00167232?
The interventions under investigation include: Naltrexone (DRUG).
Who is sponsoring clinical trial NCT00167232?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00167232's enrollment target sits among peer trials
164 1470th of 2000 higher than 530 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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