Sweet Preference and Alcohol Craving

NCT01296646 | Completed Phase 2 Results DMC

• 2 other identifiers: 09-09391R21AA017503-01A2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Dependence; Alcohol Abuse

Keywords

Alcohol; Alcoholics; Substance Abuse; Alcohol Abuse; Alcohol Addiction

Outcome Measures

Primary Outcomes (1)

• Percent Heavy Drinking Days

  Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.

  12 weeks

Secondary Outcomes (1)

• Percent Days Abstinent

  12 weeks

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Sweet Liker, High Craver Half of this group will be on naltrexone the other half will be on placebo. All subjects will receive Brenda Therapy Sessions

Drug: Naltrexone; Behavioral: Brenda Therapy Sessions; Drug: Placebo

Arm 2

ACTIVE COMPARATOR

Sweet Liker - Low Craver Half of this group will be on naltrexone the other half will be on placebo. All subjects will receive Brenda Therapy Sessions

Drug: Naltrexone; Behavioral: Brenda Therapy Sessions; Drug: Placebo

Arm 3

ACTIVE COMPARATOR

Sweet Disliker - High Craver. Half of this group will be on naltrexone the other half will be on Placebo. All subjects will receive Brenda Therapy Sessions

Drug: Naltrexone; Behavioral: Brenda Therapy Sessions; Drug: Placebo

Arm 4

ACTIVE COMPARATOR

Sweet Disliker - Low Craver; half of this group will be on naltrexone the other half on placebo. All subjects will receive Brenda Therapy Sessions

Drug: Naltrexone; Behavioral: Brenda Therapy Sessions; Drug: Placebo

Interventions

Naltrexone DRUG

50 mg oral naltrexone once/day

Also known as: Revia

Arm 1; Arm 2; Arm 3; Arm 4

Brenda Therapy Sessions BEHAVIORAL

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.

Also known as: Counselling, Therapy Sessions, Medical Management

Arm 1; Arm 2; Arm 3; Arm 4

Placebo DRUG

An inactive pill to control for non-pharmacological responses.

Also known as: "Sugar pill"

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol dependence.
• 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.
• Ability to understand and sign written informed consent.
• Must have a 0.0 gms/dL breathalyzer reading on the day of screening and 0.0 gms/dL on the day of randomization.
• Must be willing to refrain from drinking for three days prior to randomization day.
• Express a desire to achieve abstinence or to greatly reduce alcohol consumption.
• Must have a stable residence and be able to identify an individual who could locate subject if needed.

You may not qualify if:

• 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).
• Clinically significant psychiatric illness including: any psychotic disorder, bipolar disorder, severe depression, or suicidal ideation.
• Other substance abuse or dependence disorder other than nicotine or alcohol.
• 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.
• History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
• AST, or ALT \> 3 times Upper Limit of Normal (ULN) or bilirubin \> ULN.
• 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.
• 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.
• Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
• Participation in any clinical trial within the past 60 days.
• Court-mandated participation in alcohol treatment or pending incarceration.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Garbutt JC, Kampov-Polevoy AB, Kalka-Juhl LS, Gallop RJ. Association of the Sweet-Liking Phenotype and Craving for Alcohol With the Response to Naltrexone Treatment in Alcohol Dependence: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Oct 1;73(10):1056-1063. doi: 10.1001/jamapsychiatry.2016.2157.

  PMID: 27627782 DERIVED

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Interventions

Naltrexone; Counseling; Practice Management, Medical; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Carbohydrates

Results Point of Contact

• Title: James C. Garbutt, M.D., Professor of Psychiatry
• Organization: University of North Carolina at Chapel Hill

jc_garbutt@med.unc.edu

919-966-4652

Study Officials

• James C Garbutt, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-10

Locations

US (1)