Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

NCT02859142 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 15-1615
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Alcohol Drinking

Keywords

Varenicline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks

  12 weeks

• Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks

  26 weeks

• Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks

  12 weeks

• Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks

  26 weeks

• Change From Baseline Smoking Abstinence Rates at 26 Weeks

  26 weeks

Study Arms (2)

Augmented Treatment

EXPERIMENTAL

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; Behavioral: Behavioral Counseling Sessions; Drug: NicodermCQ

Standard Treatment w/ placebo

ACTIVE COMPARATOR

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; Drug: NicodermCQ; Drug: Placebo

Interventions

Chantix DRUG

Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]

Also known as: Varenicline Tartrate

Augmented Treatment

Behavioral Counseling Sessions BEHAVIORAL

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

Augmented Treatment; Standard Treatment w/ placebo

NicodermCQ DRUG

Nicotine patches provided over 12 week participation

Also known as: Transdermal Nicotine Patch

Augmented Treatment; Standard Treatment w/ placebo

Placebo DRUG

Identical in appearance to varenicline \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]

Standard Treatment w/ placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Pfizer: collaborator

Study Sites (1)

Clinical Addictions Research Laboratory

Chicago, Illinois, 60637, United States

Location

Related Publications (8)

• 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.

  PMID: 15887955 BACKGROUND

• 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.

  PMID: 20306175 BACKGROUND

• 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.

  PMID: 15528443 BACKGROUND

• 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.

  PMID: 16820547 BACKGROUND

• 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.

  PMID: 25005652 BACKGROUND

• Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  PMID: 39868569 DERIVED

• 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.

  PMID: 35244704 DERIVED

• 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.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Alcohol Drinking

Interventions

Varenicline; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics

Results Point of Contact

• Title: Andrea King, Ph.D.
• Organization: University of Chicago

aking@yoda.bsd.uchicago.edu

7737026181

Study Officials

• Andrea King, Ph.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 8, 2016
• Study Start: March 29, 2018
• Primary Completion: September 30, 2020
• Study Completion: October 15, 2020
• Last Updated: September 27, 2021
• Results First Posted: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)