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Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02859142
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Alcohol Drinking Drug: Chantix Behavioral: Behavioral Counseling Sessions Drug: NicodermCQ Phase 4

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 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 in this effectiveness study. 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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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.

  • 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
Chantix given alongside standard smoking cessation treatment
Other Name: Varenicline Tartrate

Behavioral: Behavioral Counseling Sessions
One-to-one behavioral counseling sessions with a trained therapist

Drug: NicodermCQ
Nicotine patches provided over 12 week participation
Other Name: Transdermal Nicotine Patch

Active Comparator: Standard Treatment

Participants receive 12 weeks of standard smoking cessation treatment of nicotine patches and behavioral counseling visits.

  • 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
One-to-one behavioral counseling sessions with a trained therapist

Drug: NicodermCQ
Nicotine patches provided over 12 week participation
Other Name: Transdermal Nicotine Patch




Primary Outcome Measures :
  1. Change from Baseline Smoking Abstinence Rates at 12 weeks [ Time Frame: 12 weeks ]
    Change in number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.


Secondary Outcome Measures :
  1. Change from Baseline in Self-Reported Alcohol Drinking Days at 12 weeks [ Time Frame: 12 weeks ]
    Change from baseline in self reported monthly drinking days obtained via a past month Timeline Followback Calendar at 12 weeks

  2. Change from Baseline in Self-Reported Alcohol Drinking Days at 26 weeks [ Time Frame: 26 weeks ]
    Change from baseline in self reported monthly drinking days obtained via a past month Timeline Followback Calendar at 26 weeks

  3. Change from Baseline in Self-Reported Percent Heavy Drinking Days at 12 weeks [ Time Frame: 12 weeks ]
    Change from baseline in self reported percent heavy drinking days obtained via a past month Timeline Followback Calendar at 12 weeks

  4. Change from Baseline in Self-Reported Percent Heavy Drinking Days at 26 weeks [ Time Frame: 26 weeks ]
    Change from baseline in self reported percent heavy drinking days obtained via a past month Timeline Followback Calendar at 12 weeks

  5. Change from Baseline Smoking Abstinence Rates at 26 weeks [ Time Frame: 26 weeks ]
    Change in number of participants reporting smoking abstinence at 26 weeks from baseline (smoking quit date) via subjective and biologically verified reports.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859142


Contacts
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Contact: Andrea King, PhD 7737026181 aking@bsdad.uchicago.edu

Locations
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United States, Illinois
Clinical Addictions Research Laboratory Recruiting
Chicago, Illinois, United States, 60637
Contact: Ashley Vena, PhD    773-834-8654    avena1@yoda.bsd.uchicago.edu   
Principal Investigator: Andrea C King, PhD         
Sponsors and Collaborators
University of Chicago
Pfizer
Investigators
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Principal Investigator: Andrea King, Ph.D. University of Chicago

Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02859142     History of Changes
Other Study ID Numbers: 15-1615
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Chicago:
Varenicline

Additional relevant MeSH terms:
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Varenicline
Alcohol Drinking
Alcoholic Intoxication
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action