CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 112 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline: 0.5 mg once daily (days 1–3), 0.5 mg twice daily (days 4–7), then 1 mg twice daily (days 8–84)AI-extracted
Key inclusion· 7
  • Age 18 or older
  • Smoked at least 100 cigarettes lifetime
  • Current smoking: 5 or more cigarettes per day
  • Interested in quitting smoking (preparation or contemplation stage)
Key exclusion· 4
  • Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
  • Psychiatric instability
  • Pregnancy or breastfeeding, or contemplating pregnancy
  • Creatinine clearance < 30 mL/min

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01027754
NCT01027754Phase 4Completed

Smoking Cessation Treatment for Methadone Maintenance Patients

Albert Einstein College of Medicine·interventional·Posted Dec 9, 2009·Updated May 26, 2021

In Brief

A Phase 4 clinical trial evaluating Varenicline and Placebo for Smoking Cessation and Substance-Related Disorders. Completed, enrolled 112 participants across 1 site.

Detailed Summary

Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartAug 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.6 years ago

Interventions

Vareniclinedrug

Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day

Placebodrug

Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily