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Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

NCT02859142 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-09-27

Study results available
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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

Interventions

DRUG

Chantix

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

BEHAVIORAL

Behavioral Counseling Sessions

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

DRUG

NicodermCQ

Nicotine patches provided over 12 week participation

DRUG

Placebo

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Andrea King, Ph.D. · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2020-09-30
Completion
2020-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859142 on ClinicalTrials.gov