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NCT01296646 · ClinicalTrials.gov registry record · Phase 2
Sweet Preference and Alcohol Craving
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT01296646 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants.
The verdict
NCT01296646, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
Purpose: The proposed 2-year investigation will be the first double-blind, placebo-controlled trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes-Sweet Likers (SL) and Sweet Dislikers (SDL). Based on preliminary findings, HRST will be examined in conjunction with craving for alcohol to assess whether the two factors together provide a more robust predictor of NTX response. The identification of methods to predict naltrexone response in alcohol dependence is an important goal for alcohol treatment research. Currently naltrexone is not being used nearly as much as it should be, in part because clinicians do not believe it is very effective. The development of tools that would identify which patients are more likely to have a robust response to naltrexone should lead to increased use of the medication. This could help many patients who are not now having the opportunity of trying naltrexone. There are two principal Specific Aims for the study: Specific Aim 1. To test the hypothesis that a combination of SL/SDL status and initial alcohol craving will predict % abstinent days (%ABST) during treatment with naltrexone. Specific Aim 2. To test whether a combination of SL/SDL status and initial alcohol craving predict % heavy drinking days (%HDD) during treatment with naltrexone.
Interventions
- DRUG Placebo
- DRUG Naltrexone
- BEHAVIORAL Brenda Therapy Sessions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01296646
The ClinicalTrials.gov registry entry for NCT01296646 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01296646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01296646 about?
NCT01296646 is a clinical study titled "Sweet Preference and Alcohol Craving". Purpose: The proposed 2-year investigation will be the first double-blind, placebo-controlled trial examining the hedonic response to sweet taste (HRST) as a phenotypic predictor of naltrexone (NTX) response in alcohol dependence. HRST yields two primary phenotypes-Sweet Likers (SL) and Sweet Dislik...
What is the current status of trial NCT01296646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2010-01. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01296646?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG), Brenda Therapy Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT01296646?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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