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NCT00568958 · ClinicalTrials.gov registry record · Phase 4
Naltrexone for Heavy Drinking in Young Adults
A Phase 4 study of Alcoholism and Alcohol Consumption, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT00568958: Completed Phase 4 study of Alcoholism and Alcohol Consumption, sponsored by Yale University.
NCT00568958 is a Phase 4 study of Alcoholism and Alcohol Consumption that has completed, run by Yale University. The registered enrollment target is 140 participants, below the 373-participant average among 65 other Alcoholism trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00568958, a Phase 4 study of Alcoholism and Alcohol Consumption, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.
Primary Outcome
Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or
Conditions Studied
Interventions
- DRUG naltrexone
- BEHAVIORAL BASICS counseling
- DRUG placebo naltrexone
Study Locations (1)
Connecticut
- Connecticut Mental Health Center - Substance Abuse Treatment Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT00568958 record still lists
NCT00568958 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 373-participant average among 65 other Alcoholism trials with a reported enrollment target (62% lower).
The record links to 4 conditions, with Alcoholism appearing as the primary indexed condition, and to 3 interventions - of which naltrexone is the first listed.
NCT00568958 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT00568958 about?
NCT00568958 is a clinical study titled "Naltrexone for Heavy Drinking in Young Adults". In this study, 140 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrex...
What is the current status of trial NCT00568958?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2008-02. Estimated completion is 2012-12.
What conditions does trial NCT00568958 study?
This clinical trial studies the following conditions: Alcoholism, Alcohol Consumption, Alcoholic Intoxication, Alcohol-induced Disorders.
What interventions are being tested in trial NCT00568958?
The interventions under investigation include: naltrexone (DRUG), BASICS counseling (BEHAVIORAL), placebo naltrexone (DRUG).
Who is sponsoring clinical trial NCT00568958?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00568958 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcoholism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00568958's enrollment target sits among peer trials
140 28th of 65 higher than 38 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism 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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