Sweet Preference and Alcohol Craving
Condition: Alcohol Dependence; Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Participants: There will be 130 alcohol-dependent individuals between 18 and 65 years of age
      recruited to participate in this randomized placebo-controlled clinical trial. Eighty
      alcohol-dependent individuals will be randomized into the study and we are allowing for 50
      screen failures. Participation in this study will be an alternative to standard treatment.
      Subjects will be blindly assessed for SL/SDL status to yield 50% representation of each
      trait.

      Procedures (methods): Subjects who meet general inclusion/exclusion criteria based on the
      screening interview will complete a sweet taste assessment. Results, along with craving
      score, will be given to the Investigational Drug Services for randomization purposes. The
      study is a double-blind, randomized, placebo-controlled clinical trial in which participants
      will receive 50 mg oral naltrexone or matching placebo for a 12-week period. In addition
      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.
    

Intervention name(s): Naltrexone; Brenda Therapy Sessions; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): 50 mg oral naltrexone once/day; 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.; An inactive pill to control for non-pharmacological responses.
Other intervention name(s): Revia; Counselling; Therapy Sessions; Medical Management; "Sugar pill"
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol; Alcoholics; Substance Abuse; Alcohol Abuse; Alcohol Addiction