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Sweet Preference and Alcohol Craving (SweetNal)

Primary Purpose

Alcohol Dependence, Alcohol Abuse

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

Brenda Therapy Sessions

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Alcoholics, Substance Abuse, Alcohol Abuse, Alcohol Addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of North Carolina - Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Days Abstinent

Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.

Full Information

NCT ID

NCT01296646

First Posted

February 14, 2011

Last Updated

October 29, 2013

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01296646

Brief Title

Sweet Preference and Alcohol Craving

Acronym

SweetNal

Official Title

Sweet Preference and Alcohol Craving Predict Naltrexone Response in Alcoholism

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence, Alcohol Abuse

Keywords

Alcohol, Alcoholics, Substance Abuse, Alcohol Abuse, Alcohol Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Other Intervention Name(s)

Revia

Intervention Description

50 mg oral naltrexone once/day

Intervention Type

Behavioral

Intervention Name(s)

Brenda Therapy Sessions

Other Intervention Name(s)

Counselling, Therapy Sessions, Medical Management

Intervention Description

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 Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

"Sugar pill"

Intervention Description

An inactive pill to control for non-pharmacological responses.

Primary Outcome Measure Information:

Title

Percent Heavy Drinking Days

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Percent Days Abstinent

Description

Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James C Garbutt, M.D.

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina - Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27627782

Citation

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.

Results Reference

derived

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Sweet Preference and Alcohol Craving

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