Alcohol DependencePhase 2SweetNalNCT01296646
Sweet Preference and Alcohol Craving
A Phase 2 study testing Naltrexone and Brenda Therapy Sessions in people with Alcohol Dependence and Alcohol Abuse, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Alcohol Abuse
- What is being tested?
- Naltrexone and Brenda Therapy Sessions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Sweet Preference and Alcohol Craving Predict Naltrexone Response in Alcoholism
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:
Read more
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.
Read the 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.
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Being tested
- Naltrexone, Brenda Therapy Sessions, Placebo
- Keywords
- Alcohol, Alcoholics, Substance Abuse, Alcohol Abuse, Alcohol Addiction
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
50 mg oral naltrexone once/day
Brenda Therapy SessionsBehavioural
Also called Counselling, Therapy Sessions, Medical Management
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
Also called "Sugar pill"
An inactive pill to control for non-pharmacological responses.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Naltrexone; Behavioral: Brenda Therapy Sessions; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Percent Days Abstinent
Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, James Garbutt, MD, University of North Carolina, Chapel Hill
- Investigators
- James C Garbutt, M.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296646
- Sponsor's protocol ID
- 09-0939
- Other IDs
- 1R21AA017503-01A2
- Acronym
- SweetNal
- Status last verified
- Oct 2013
- First submitted
- 14 Feb 2011
- Last updated
- 25 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27627782
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Preference and Alcohol Craving Predict Naltrexone Response in Alcoholism
- ClinicalTrials.gov ID
- NCT01296646
- Acronym / sponsor ID
- SweetNal / 09-0939
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Keywords
- Alcohol, Alcoholics, Substance Abuse, Alcohol Abuse, Alcohol Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Naltrexone, Behavioral: Brenda Therapy Sessions, Drug: PlaceboSweet 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 2 | Active comparator | Drug: Naltrexone, Behavioral: Brenda Therapy Sessions, Drug: PlaceboSweet 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 3 | Active comparator | Drug: Naltrexone, Behavioral: Brenda Therapy Sessions, Drug: PlaceboSweet 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 4 | Active comparator | Drug: Naltrexone, Behavioral: Brenda Therapy Sessions, Drug: PlaceboSweet Disliker - Low Craver; half of this group will be on naltrexone the other half on placebo. All subjects will receive Brenda Therapy Sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Revia50 mg oral naltrexone once/day | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| Brenda Therapy SessionsAlso: Counselling, Therapy Sessions, Medical Managementparticipants 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. | Behavioural | Arm 1, Arm 2, Arm 3, Arm 4 |
| PlaceboAlso: "Sugar pill"An inactive pill to control for non-pharmacological responses. | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Percent Heavy Drinking Days
Time frame: 12 weeks
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.
1 secondary outcome
Percent Days Abstinent
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27627782Garbutt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Garbutt, M.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone and Brenda Therapy Sessions in people with Alcohol Dependence and Alcohol Abuse, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Heavy Drinking Days (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.