Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

Study Overview
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Brief Summary
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The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.

Detailed Description
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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.

Official Title
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Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

Conditions
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Smoking Cessation, Alcohol Drinking

Intervention / Treatment
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* Drug: Chantix
* Behavioral: Behavioral Counseling Sessions
* Drug: NicodermCQ
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Treatment<br>Participants receive 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. Chantix (Varenicline) and NicodermCQ (Nicotine Patches): Administered according to package insert directions Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. | Drug: Chantix<br>* 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]<br>* Other names: Varenicline Tartrate;Behavioral: Behavioral Counseling Sessions<br>* One-to-one behavioral counseling sessions with a trained therapist<br>Drug: NicodermCQ<br>* Nicotine patches provided over 12 week participation<br>* Other names: Transdermal Nicotine Patch;|
| Active Comparator: Standard Treatment w/ placebo<br>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 Placebo pills (identical to varenicline) NicodermCQ (Nicotine Patches): Administered according to package insert directions Behavioral Counseling Sessions: Participants will attend one-on-one behavioral counseling sessions with a trained therapist at each of 4 study visits (pre-quit, quit date, week 2, and week 12). Behavioral sessions will involve teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings. | Behavioral: Behavioral Counseling Sessions<br>* One-to-one behavioral counseling sessions with a trained therapist<br>Drug: NicodermCQ<br>* Nicotine patches provided over 12 week participation<br>* Other names: Transdermal Nicotine Patch;Drug: Placebo<br>* 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]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Smoking Abstinence Rates at 12 Weeks | Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks | Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks | 12 weeks | 
| Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks | Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks | 26 weeks | 
| Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks | 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 | 12 weeks | 
| Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks | 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 | 26 weeks | 
| Change From Baseline Smoking Abstinence Rates at 26 Weeks | Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports. | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varenicline