Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

NCT02859142

Last updated date
Study Location
Clinical Addictions Research Laboratory
Chicago, Illinois, 60637, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation, Alcohol Drinking
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Smoking Cessation, Alcohol DrinkingVarenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
NCT02859142
  1. Chicago, Illinois
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Official Title  ICMJE Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Alcohol Drinking
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Chantix
    • Behavioral: Behavioral Counseling Sessions
    • Drug: NicodermCQ
  • 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.
    Interventions:
    • Behavioral: Behavioral Counseling Sessions
    • Drug: NicodermCQ
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 12, 2020)
122
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
180
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02859142
Other Study ID Numbers  ICMJE 15-1615
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Andrea King, Ph.D.University of Chicago
PRS Account University of Chicago
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP