- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859142
Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will conduct a real-world clinic-based smoking cessation trial examining the augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral counseling versus standard treatment of patch plus behavioral counseling only in heavy drinkers who smoke (HDS). While Chantix is approved for smoking cessation, it is not routinely given in practice for HDS patients
In this study, there will be 4 total in-person study visits over the trial (pre-quit, quit date, week 2 and week 12), ending 12 weeks after the quit date. Biochemical verification from breath tests for CO, as well as vital signs and weight, will be measured at each visit along with survey responses measuring smoking urge and withdrawal, negative affect, neurocognition, and alcohol and smoking behaviors. These will also be used at a 26-week follow-up by telephone with biochemical verification for CO in those reporting being smoke-free.
Screening and Randomization Participants will respond to advertisements and will undergo a brief phone screening to determine initial eligibility requirements. Qualified candidates will be invited into the lab to conduct a short screening and study information session at the Clinical Addictions Research Laboratory at the University of Chicago. At screening, participants will sign an informed consent document. Next, demographics, smoking, alcohol and substance use patterns, health history, medications, vital signs, a urine test (for pregnancy and/or drug toxicology) and a blood test will be obtained.
Eligible participants will be randomized into one of two treatment groups: Standard Treatment (w/ placebo) will proceed with the study receiving nicotine patches and brief counseling sessions; Augmented Treatment will proceed with the same nicotine patches and brief counseling sessions, but will also receive standard dosing of Chantix (Varenicline tartrate).
Nicotine Patches Nicotine patches will be utilized starting at study quit date, and proceed according to package insert directions (10+ cigs/day smokers will begin with 21mg patches for six weeks, followed by 14mg patches for four weeks, and finally 7mg patches for two weeks. Those smoking fewer than 10 cigarettes/day will follow the same process starting at the 14mg patch level.
Chantix (Varenicline Tartrate) Those receiving Augmented Treatment will receive varenicline. They will undergo an up-titration week prior to the quit date, 12 weeks of target dosing, and a down-titration week. As per Pfizer recommendations, up-titration will be 0.5mg tablets once daily for 3 days followed by twice daily for four days leading to the quit date on day 8. The sequence will reverse for a down-titration week on week 13.
Placebo for Varenicline Those receiving standard treatment will also receive placebo medication that will be identical in appearance to and follow the same distribution protocol as varenicline.
Smoking Cessation Behavioral Sessions:
Participants will attend one-on-one behavioral counseling sessions with a trained Masters or PhD. Level therapist at each study visit. Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. At each study visit, subjective measures (i.e. brief self-report surveys about
Follow-Up Interview (Week 26) At Study Week 26, participants will complete a follow-up telephone interview, completing similar subjective measures as those completed during study visits. Participants reporting being smoke-free during this interview will arrange for biochemical verification of this status via expired CO testing either by arranging for a time to stop into one of the study sites or by arranging for study staff to meet with them in their home or workplace.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- Clinical Addictions Research Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smoke 3-30 cigarettes/day
- Desire to quit smoking as indicated on a smoking stages ladder
- Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12 oz beer, 5 oz wine, 1.5 oz liquor)
- Ability to understand, read, and write in English, at least 8th grade education
- Willing and able to sign an informed consent
- Stable residence and contact information.
Exclusion Criteria:
- Hepatic panel indices > 2 SD
- History of seizures or DTs during alcohol withdrawal
- Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations, severe depression, obsessional thinking, self-injury risking significant blood loss, etc.) deemed by the study physician to be at significant risk for adverse interactions with study medications or measures.
- History of adverse reactions to varenicline (VAR) or nicotine patch
- Current suicidal ideation (past 6 months) and/or history of major suicide attempts.
- For women of child-bearing potential: currently pregnant, lactating, current plans to become pregnant in next three months, or unable to agree to adequate birth control during study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Augmented Treatment
Participants receive 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits.
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Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
Other Names:
One-to-one behavioral counseling sessions with a trained therapist
Nicotine patches provided over 12 week participation
Other Names:
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Active Comparator: Standard Treatment w/ placebo
Participants receive 12 weeks of standard smoking cessation treatment of nicotine patches and behavioral counseling visits in addition to placebo pills identical in appearance to varenicline
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One-to-one behavioral counseling sessions with a trained therapist
Nicotine patches provided over 12 week participation
Other Names:
Identical in appearance to varenicline [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Smoking Abstinence Rates at 12 Weeks
Time Frame: 12 weeks
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Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
Time Frame: 12 weeks
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Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks
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12 weeks
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Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
Time Frame: 26 weeks
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Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks
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26 weeks
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Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
Time Frame: 12 weeks
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Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks
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12 weeks
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Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
Time Frame: 26 weeks
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Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks
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26 weeks
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Change From Baseline Smoking Abstinence Rates at 26 Weeks
Time Frame: 26 weeks
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Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports.
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26 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea King, Ph.D., University of Chicago
Publications and helpful links
General Publications
- Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56. Erratum In: JAMA. 2006 Sep 20;296(11):1355.
- Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, Sands SB, Davis TI, Lebel LA, Fox CB, Shrikhande A, Heym JH, Schaeffer E, Rollema H, Lu Y, Mansbach RS, Chambers LK, Rovetti CC, Schulz DW, Tingley FD 3rd, O'Neill BT. Varenicline: an alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem. 2005 May 19;48(10):3474-7. doi: 10.1021/jm050069n.
- Perkins KA, Mercincavage M, Fonte CA, Lerman C. Varenicline's effects on acute smoking behavior and reward and their association with subsequent abstinence. Psychopharmacology (Berl). 2010 May;210(1):45-51. doi: 10.1007/s00213-010-1816-9. Epub 2010 Mar 20.
- Tapper AR, McKinney SL, Nashmi R, Schwarz J, Deshpande P, Labarca C, Whiteaker P, Marks MJ, Collins AC, Lester HA. Nicotine activation of alpha4* receptors: sufficient for reward, tolerance, and sensitization. Science. 2004 Nov 5;306(5698):1029-32. doi: 10.1126/science.1099420.
- Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195.
- King A, Vena A, de Wit H, Grant JE, Cao D. Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220951. doi: 10.1001/jamanetworkopen.2022.0951.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholic Intoxication
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
- Varenicline
Other Study ID Numbers
- 15-1615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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