CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Naltrexone +2 moredrug
Likely dose
Naltrexone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01296646
NCT01296646Phase 2Completed

Sweet Preference and Alcohol Craving Predict Naltrexone Response in Alcoholism

University of North Carolina, Chapel Hill·interventional·Posted Feb 15, 2011·Updated Nov 25, 2013

In Brief

A Phase 2 clinical trial evaluating Naltrexone, Brenda Therapy Sessions, and 1 other intervention for Alcohol Dependence and Alcohol Abuse. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2011
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.4 years ago

Interventions

Naltrexonedrug

50 mg oral naltrexone once/day

Brenda Therapy Sessionsbehavioral

participants will meet with a trained therapist for nine 30-minute BRENDA therapy sessions Medical monitoring will also be conducted by study physicians and will consist of review of vital signs, concomitant medication use, and general inquiries into side effects.

Placebodrug

An inactive pill to control for non-pharmacological responses.