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NCT00115037 · ClinicalTrials.gov registry record · Phase 4
Managing Alcoholism in People Who Do Not Respond to Naltrexone
A Phase 4 study of Alcoholism, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 302
- Enrollment target
- 1
- Study location
NCT00115037 is a Phase 4 study of Alcoholism that has completed, run by University of Pennsylvania. The registered enrollment target is 302 participants, below the 370-participant average among 65 other Alcoholism trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00115037, a Phase 4 study of Alcoholism, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 302 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in motivating patients to greater medication adherence and may address psychosocial factors that may limit the effects of naltrexone.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Naltrexone
- BEHAVIORAL Telephone Counseling
- BEHAVIORAL Medication Management (MM)
- BEHAVIORAL Combined Behavioral Intervention (CBI)
Study Locations (1)
Pennsylvania
- University of Pennsylvania Treatment Research Center, Chestnut Street - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2003-09 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115037
The ClinicalTrials.gov registry entry for NCT00115037 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 370-participant average among 65 other Alcoholism trials with a reported enrollment target (18% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.
NCT00115037 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00115037 about?
NCT00115037 is a clinical study titled "Managing Alcoholism in People Who Do Not Respond to Naltrexone". This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized plac...
What is the current status of trial NCT00115037?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2003-09. Estimated completion is 2008-07.
What conditions does trial NCT00115037 study?
This clinical trial studies the following conditions: Alcoholism.
What interventions are being tested in trial NCT00115037?
The interventions under investigation include: placebo (DRUG), Naltrexone (DRUG), Telephone Counseling (BEHAVIORAL), Medication Management (MM) (BEHAVIORAL), Combined Behavioral Intervention (CBI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT00115037?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00115037 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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