Nicotine DependencePhase 1NCT02151591
New Approaches to Smoking Cessation in Heavy Drinkers
A Phase 1 study testing Varenicline in people with Nicotine Dependence and Cigarette Smoking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nicotine Dependence, Cigarette Smoking, Alcohol Consumption
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Aug 2018
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are at least 18 years of age;
- report smoking 100 cigarettes over lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of >=30ng/mL by semi-quantitative analysis, and/or >= 2 on a NicAlert dipstick
- are interested in quitting smoking;
- understand English;
- exceed National Institute on Alcohol Abuse and Alcoholism heavy drinking criteria (i.e., for men, >14 drinks/week or 5 drinks/day at least once per month over the past 12 months; for women, >7 drinks/week or >4 drinks/day at least once per month over the past 12 months.
Who cannot join
- meet criteria for alcohol dependence in the past 12 months that is clinically severe defined by
- a history of seizures, delirium, or hallucinations during alcohol withdrawal;
- a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of > 8;
- report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal;
- have required medical treatment of alcohol withdrawal within the past 6 months;
- are currently enrolled in alcohol treatment;
Show all 24Show fewer
- meet criteria for drug dependence in the past 12 months; with the exception of marijuana dependence
- exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination;
- report current suicidality (past 12 months), or report suicide attempts within the past 10 years, assessed with the Columbia Suicide Severity Rating Scale;
- exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
- any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin);
- clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
- hepatic or renal impairment;
- severe obstructive pulmonary disease;
- diabetes mellitus requiring insulin or certain oral medications (i.e., sulfonylureas) and an A1C hemoglobin test score of > 7 for participants not prescribed these medications;
- baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg;
- are cognitively impaired;
- are unable to read/understand English;
- are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
- report new onset of psychiatric disorders or new psychotropic medications within the past 3 months, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months or who report occasional use of prescription sleep aids that they are willing to discontinue;
- have used another investigational drug within 30 days or have used medications to treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months or intend to use these medications; (prior use of nicotine replacement in situations where smoking is not permitted (e.g., planes) without the intention to quit smoking is not exclusionary at screening)
- intend to donate blood or blood products during the treatment phase of the study;
- have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin);
- have a history of serious hypersensitivity reactions or skin reactions to varenicline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
The purpose of this study is to develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a 12-week treatment phase in which participants receive varenicline (Chantix) and weekly, personalized counseling.
Read the detailed description
The purpose of the proposed project is to develop and test a 12-week integrated cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline (Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases. In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy drinking smokers. The primary results of this phase will be used to refine the CBT for SA protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy drinking smokers comparing CBT for SA with standard smoking counseling (SC). All participants in the randomized pilot study will also receive varenicline (Chantix).
Primary and Study Completion dates were changed 6/2016 to reflect an additional year added year to the study.
- Being tested
- Varenicline
- Keywords
- Quit smoking, Quit drinking
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
12-weeks of treatment. Dose will be titrated as follows:
Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
| Study group | Role | What they receive |
|---|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | Experimental | Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Receives: Drug: Varenicline |
| Standard Care for Primary Presenting Concern (SC) | Other | Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Smoking Abstinence at 6 Months
Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.
Measured: 6 months post treatment start
Secondary outcomes (2)
Log Transformed Percentage of Heavy Drinking Days
Log transformed percentage of heavy drinking days 6 months post treatment start.
Measured: 6 months post treatment start
Number of Participants Who Completed Treatment.
To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.
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 posted30 May 2014 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
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 Nicotine DependenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 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
- Sponsor
- Investigators
- Lisa Fucito, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151591
- Sponsor's protocol ID
- 1106008673
- Other IDs
- K23AA020000-01A1
- Status last verified
- Feb 2020
- First submitted
- 27 May 2014
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be made available to researchers who request data from the PI
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approaches to Smoking Cessation in Heavy Drinkers
- ClinicalTrials.gov ID
- NCT02151591
- Acronym / sponsor ID
- 1106008673
- Keywords
- Quit smoking, Quit drinking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 10 Feb 2020
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 develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a 12-week treatment phase in which participants receive varenicline (Chantix) and weekly, personalized counseling.
Detailed description
The purpose of the proposed project is to develop and test a 12-week integrated cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline (Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases. In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy drinking smokers. The primary results of this phase will be used to refine the CBT for SA protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy drinking smokers comparing CBT for SA with standard smoking counseling (SC). All participants in the randomized pilot study will also receive varenicline (Chantix).
Primary and Study Completion dates were changed 6/2016 to reflect an additional year added year to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Counseling for Tobacco and Alcohol (INT) | Experimental | Drug: VareniclineIntegrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). |
| Standard Care for Primary Presenting Concern (SC) | Other | Drug: VareniclineStandard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are at least 18 years of age;
- report smoking 100 cigarettes over lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of >=30ng/mL by semi-quantitative analysis, and/or >= 2 on a NicAlert dipstick
- are interested in quitting smoking;
- understand English;
- exceed National Institute on Alcohol Abuse and Alcoholism heavy drinking criteria (i.e., for men, >14 drinks/week or 5 drinks/day at least once per month over the past 12 months; for women, >7 drinks/week or >4 drinks/day at least once per month over the past 12 months.
Key exclusion criteria (24 listed)
- meet criteria for alcohol dependence in the past 12 months that is clinically severe defined by
- are currently enrolled in alcohol treatment;
- meet criteria for drug dependence in the past 12 months; with the exception of marijuana dependence
- exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination;
- report current suicidality (past 12 months), or report suicide attempts within the past 10 years, assessed with the Columbia Suicide Severity Rating Scale;
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: Chantix12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day | Drug | Integrated Counseling for Tobacco and Alcohol (INT), Standard Care for Primary Presenting Concern (SC) |
Primary outcome
Number of Participants With Smoking Abstinence at 6 Months
Time frame: 6 months post treatment start
Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.
2 secondary outcomes
Log Transformed Percentage of Heavy Drinking Days
Time frame: 6 months post treatment start
Number of Participants Who Completed 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 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be made available to researchers who request data from the PI
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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.
Lisa Fucito, 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 1 study testing Varenicline in people with Nicotine Dependence and Cigarette Smoking, 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 5 inclusion and 24 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 24 Feb 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Feb 2020). 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 Smoking Abstinence at 6 Months (time frame: 6 months post treatment start). 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 24 Feb 2020.