Sweet Preference and Alcohol Craving
Condition: Alcohol Dependence; Alcohol Abuse
MeSH terms: Alcoholism
Intervention: Naltrexone; Brenda Therapy Sessions; Placebo
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol; Alcoholics; Substance Abuse; Alcohol Abuse; Alcohol Addiction

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 65 meeting DSM-IV criteria for current
             alcohol dependence.

          2. More than 14 drinks (women) or 21 drinks (men) per week including at least 2 heavy
             drinking days/week on average (men > 5 drinks/day; women > 4 drinks/day) during a
             consecutive 30-day period within the 90 days prior to screening.

          3. Ability to understand and sign written informed consent.

          4. Must have a 0.0 gms/dL breathalyzer reading on the day of screening and 0.0 gms/dL on
             the day of randomization.

          5. Must be willing to refrain from drinking for three days prior to randomization day.

          6. Express a desire to achieve abstinence or to greatly reduce alcohol consumption.

          7. Must have a stable residence and be able to identify an individual who could locate
             subject if needed.

        Exclusion Criteria:

          1. Clinically significant medical disease that might interfere with the evaluation of the
             study medication or present a safety concern (e.g., cirrhosis, unstable hypertension,
             seizure disorder, use of opiate medication).

          2. Clinically significant psychiatric illness including: any psychotic disorder, bipolar
             disorder, severe depression, or suicidal ideation.

          3. Other substance abuse or dependence disorder other than nicotine or alcohol.

          4. Concurrent use of any psychotropic medication including antidepressants, mood
             stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception
             of stable doses of antidepressants for one month.

          5. History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium
             tremens.

          6. AST, or ALT > 3 times Upper Limit of Normal (ULN) or bilirubin > ULN.

          7. Positive urine toxicology screen with the exception of cannabis. Individuals with
             positive cannabis screens will be excluded only if they have a history of cannabis
             dependence.

          8. Pregnant women and women of childbearing potential who do not practice a medically
             acceptable form of birth control (oral or depot contraceptive, or barrier methods such
             as diaphragm or condom with spermicidal) and women who are breast feeding.

          9. Individuals requiring inpatient treatment or more intense outpatient treatment for
             their alcohol dependence.

         10. Participation in any clinical trial within the past 60 days.

         11. Court-mandated participation in alcohol treatment or pending incarceration.