Binge DrinkingPhase 2NCT02842073
An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
A Phase 2 study testing Naltrexone and Bupropion in people with Binge Drinking, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers. Read more about this study
- Who is it for?
- Ages 21 to 34 years
- Conditions the study is for
- Binge Drinking
- What is being tested?
- Naltrexone and Bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 13 Dec 2017
- 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 21 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between the ages of 21 and 34 years.
- A minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder.
- 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 have a stable residence and be able to identify an individual who could contact participant if needed.
- Have a goal of sobriety or significantly reducing alcohol intake.
Who cannot join
- Presence of physical dependence on alcohol as assessed by clear tolerance to alcohol or alcohol withdrawal symptoms based on SCID interview or a Severe Alcohol Use Disorder (>5 SCID DSM-V symptoms).
- Bupropion is contraindicated in individuals with a history of bulimia or a seizure disorder and naltrexone is contraindicated in acute liver disease and in patients using or misusing opioids.
- Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, diabetes mellitus, seizure disorder). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, anorexia/bulimia, severe depression, or suicidal ideation.
- Other substance abuse or dependence disorder other than nicotine or cannabis abuse.
- Concurrent use of anticonvulsants. 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. Bupropion is commonly added to antidepressants for augmentation so the use of another antidepressant does not represent a safety concern. Prior history of adverse reaction to bupropion or naltrexone.
- AST or ALT > 3.5 times ULN or bilirubin > 1.5 X ULN.
Show all 12Show 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).
- Women who are breastfeeding.
- Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol problems.
- Participation in any clinical trial within the past 60 days that would have safety concerns for the trial.
- 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 at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Assessing Changes in the Brain Melanocortin System and Sensory Processing in Response to Alcohol to Advance Our Understanding of the Pathophysiology and Psychopharmacology of Binge Drinking
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.
Read the detailed description
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.
Participants: Investigators will recruit 12 men or women ages 21-34 years who exhibit a minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder. Subjects with overt physical dependence on alcohol, significant medical problems including seizures or bulimia, other substance use disorder except for occasional marijuana (based on toxicology screen) or significant psychiatric illness will be excluded.
Procedures (methods): As a first step in human trials investigators will give open label bupropion + naltrexone to active binge drinking subjects. The primary goal here is to assess tolerability and acceptability though changes in binge drinking and subjective sense of "effect" will be gathered as well. Investigators will also test cortical adaptation to binge drinking by completing tactile sensory testing and comparing the results to controls and individuals with overt physical dependence on alcohol. Investigators will recruit subjects using the e-mail listserve for UNC students, faculty and staff.
Investigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) and naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. Subjects will be seen at screening and then at Weeks 0, 1, 3, 5, 8 and 12. Subjects will be breathalyzed and receive Medical Management counseling to encourage compliance and progress towards drinking goals. Investigators will use the Time Line Follow-Back approach to assess alcohol consumption history modified to include time taken to consume alcohol and define a binge. They will also measure craving for alcohol and will assess tolerability by probing for adverse effects. Key outcomes of interest include tolerability and acceptability, drinking behavior including frequency and intensity of binge drinking, and craving for alcohol. Because this is an open-label trial without a placebo comparison group no formal statistics will be completed and efficacy will not be assessed. Instead, this pilot study will inform investigators about the recruitment of binge drinkers, the tolerability and acceptability of bupropion/naltrexone in this population and potential efficacy signals.
- Conditions
- Binge Drinking
- Being tested
- Naltrexone, Bupropion
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Standard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.
BupropionDrug
Standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and Buproprion | Experimental | Investigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) and naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. Receives: Drug: Naltrexone; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Associated Adverse Events
Tolerability assessed by specifically probing for intervention-associated adverse effects.
Measured: 12 weeks
Number of Participants Discontinuing Subsequent to Defined Intolerance
Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.
Measured: Throughout study, a total of approximately 12 weeks
Number of Binge Drinking Days During Treatment
The number of binge drinking days during treatment with bupropion + naltrexone
Measured: 12 weeks
Secondary outcomes (2)
Final Penn Alcohol Craving Scale (PACS) Score
Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.
Measured: 12 weeks
Mean Number of Drinks/Binge Drinking Day During Treatment
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 posted22 Jul 2016 (estimated)
- Study start1 Nov 2016
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
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.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- James Garbutt, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842073
- Sponsor's protocol ID
- 16-1370
- Other IDs
- TTSA018P1
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2016
- Last updated
- 26 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Changes in the Brain Melanocortin System and Sensory Processing in Response to Alcohol to Advance Our Understanding of the Pathophysiology and Psychopharmacology of Binge Drinking
- ClinicalTrials.gov ID
- NCT02842073
- Acronym / sponsor ID
- 16-1370
- Conditions
- Binge Drinking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Posted 26 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.
Detailed description
This is an open-label Phase IIa pilot study of the tolerability and effects on binge drinking of bupropion and naltrexone for binge drinkers.
Participants: Investigators will recruit 12 men or women ages 21-34 years who exhibit a minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder. Subjects with overt physical dependence on alcohol, significant medical problems including seizures or bulimia, other substance use disorder except for occasional marijuana (based on toxicology screen) or significant psychiatric illness will be excluded.
Procedures (methods): As a first step in human trials investigators will give open label bupropion + naltrexone to active binge drinking subjects. The primary goal here is to assess tolerability and acceptability though changes in binge drinking and subjective sense of "effect" will be gathered as well. Investigators will also test cortical adaptation to binge drinking by completing tactile sensory testing and comparing the results to controls and individuals with overt physical dependence on alcohol. Investigators will recruit subjects using the e-mail listserve for UNC students, faculty and staff.
Investigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) and naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. Subjects will be seen at screening and then at Weeks 0, 1, 3, 5, 8 and 12. Subjects will be breathalyzed and receive Medical Management counseling to encourage compliance and progress towards drinking goals. Investigators will use the Time Line Follow-Back approach to assess alcohol consumption history modified to include time taken to consume alcohol and define a binge. They will also measure craving for alcohol and will assess tolerability by probing for adverse effects. Key outcomes of interest include tolerability and acceptability, drinking behavior including frequency and intensity of binge drinking, and craving for alcohol. Because this is an open-label trial without a placebo comparison group no formal statistics will be completed and efficacy will not be assessed. Instead, this pilot study will inform investigators about the recruitment of binge drinkers, the tolerability and acceptability of bupropion/naltrexone in this population and potential efficacy signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and Buproprion | Experimental | Drug: Naltrexone, Drug: BupropionInvestigators will use standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) and naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women between the ages of 21 and 34 years.
- A minimum of 5/3 (men/women) or more binge drinking episodes per month over the past three months. A binge drinking episode is defined as the consumption of 5/4 (men/women) standard drinks (~12 gms ethanol) in about a two hour period. Subjects may meet DSM-V criteria for mild or moderate alcohol use disorder.
- 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 have a stable residence and be able to identify an individual who could contact participant if needed.
Key exclusion criteria (12 listed)
- Presence of physical dependence on alcohol as assessed by clear tolerance to alcohol or alcohol withdrawal symptoms based on SCID interview or a Severe Alcohol Use Disorder (>5 SCID DSM-V symptoms).
- Bupropion is contraindicated in individuals with a history of bulimia or a seizure disorder and naltrexone is contraindicated in acute liver disease and in patients using or misusing opioids.
- Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, diabetes mellitus, seizure disorder). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, anorexia/bulimia, severe depression, or suicidal ideation.
- Other substance abuse or dependence disorder other than nicotine or cannabis abuse.
- Concurrent use of anticonvulsants. 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. Bupropion is commonly added to antidepressants for augmentation so the use of another antidepressant does not represent a safety concern. Prior history of adverse reaction to bupropion or naltrexone.
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 |
|---|---|---|
| NaltrexoneStandard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84. | Drug | Naltrexone and Buproprion |
| BupropionStandard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84. | Drug | Naltrexone and Buproprion |
Primary outcome
Number of Participants With Treatment-Associated Adverse Events
Time frame: 12 weeks
Tolerability assessed by specifically probing for intervention-associated adverse effects.
Number of Participants Discontinuing Subsequent to Defined Intolerance
Time frame: Throughout study, a total of approximately 12 weeks
Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.
Number of Binge Drinking Days During Treatment
Time frame: 12 weeks
The number of binge drinking days during treatment with bupropion + naltrexone
2 secondary outcomes
Final Penn Alcohol Craving Scale (PACS) Score
Time frame: 12 weeks
Mean Number of Drinks/Binge Drinking Day During Treatment
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 26 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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 Garbutt principal investigator
UNC 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 Bupropion in people with Binge Drinking, 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 6 inclusion and 12 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 26 Dec 2018. 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 26 Dec 2018). 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?
Number of Participants With Treatment-Associated Adverse Events (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2018.