Alcohol DrinkingPhase 2NCT00580645
Do Treatments for Smoking Cessation Affect Alcohol Drinking?
A Phase 2 study testing varenicline in people with Alcohol Drinking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years old or older
- Able to read and write in English
- Smokers, non-daily smokers, and non-smokers
- Heavy Drinkers and/or meet criteria for alcohol use disorders
Who cannot join
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
- Prescription of any psychotropic drug in the 30 days prior to study enrollment
Show all 12Show fewer
- Blood donation within the past 8 weeks
- Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
- Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
- Known allergy to varenicline or taking H2blockers
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
- Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
New Haven, Connecticut, 06519
About this study
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.
Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.
Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
- Conditions
- Alcohol Drinking
- Being tested
- varenicline, placebo
- Keywords
- alcohol, smoking cessation, varenicline, bupropion, smoking cessation medications
- Medical subject headings
- Alcohol Drinking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
2mg/day or 1mg/day with 1-week medication lead-in period.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Experimental | varenicline 1mg/day or 2mg/day Receives: Drug: varenicline |
| Placebo | Placebo comparator | Placebo Controlled Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Consumed
number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
Measured: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
Secondary outcomes (1)
Alcohol Craving
alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)
Measured: during laboratory session (Day 8) at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2016
- Study completionNov 2016
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 DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sherry McKee, Yale University
- Investigators
- Sherry A McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580645
- Sponsor's protocol ID
- HIC0702002391
- Other IDs
- R01AA015596-01
- Status last verified
- Jan 2018
- First submitted
- 25 Dec 2007
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161.
PubMed 29389170
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Treatments for Smoking Cessation Affect Alcohol Drinking?
- ClinicalTrials.gov ID
- NCT00580645
- Acronym / sponsor ID
- HIC0702002391
- Conditions
- Alcohol Drinking
- Keywords
- alcohol, smoking cessation, varenicline, bupropion, smoking cessation medications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2007 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.
Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.
Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Experimental | Drug: vareniclinevarenicline 1mg/day or 2mg/day |
| Placebo | Placebo comparator | Drug: placeboPlacebo Controlled |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years old or older
- Able to read and write in English
- Smokers, non-daily smokers, and non-smokers
- Heavy Drinkers and/or meet criteria for alcohol use disorders
Key exclusion criteria (12 listed)
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
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 |
|---|---|---|
| vareniclineAlso: Chantix2mg/day or 1mg/day with 1-week medication lead-in period. | Drug | varenicline |
| placeboplacebo | Drug | Placebo |
Primary outcome
Number of Drinks Consumed
Time frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
1 secondary outcome
Alcohol Craving
Time frame: during laboratory session (Day 8) at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29389170Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161.
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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.
Sherry A McKee, PhD principal investigator
Yale University
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 varenicline in people with Alcohol Drinking, run by Yale University 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 4 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 7 Feb 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. Some participants in this study may receive a placebo. 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 7 Feb 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 Drinks Consumed (time frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8)). 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 NCT00580645, 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 7 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.