Phase 4
Completed N=122
Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
Smoking Cessation · Alcohol Drinking
Source: ClinicalTrials.gov NCT02859142 ↗
Enrolled (actual)
122
Serious AEs
1.6%
Results posted
Sep 2021
Primary outcomePrimary: Change From Baseline Smoking Abstinence Rates at 12 Weeks — 27; 17 Participants
◆ Published Evidence
Highly cited
112citations · ~22 / year
Interventions for preventing weight gain after smoking cessation.
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.
Linked Publications (3)
-
Interventions for preventing weight gain after smoking cessation.
-
Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial.
-
Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Smoking Abstinence Rates at 12 Weeks |
27; 17 | — |
| SECONDARY Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks |
12.25; 11.96 | — |
| SECONDARY Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks |
12.73; 11.44 | — |
| SECONDARY Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks |
5.02; 5.58 | — |
| SECONDARY Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks |
4.79; 5.56 | — |
| SECONDARY Change From Baseline Smoking Abstinence Rates at 26 Weeks |
15; 16 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02859142) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.