At a glance
ClinicalIndex Comparison Record- ✓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)
- ✕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.
Smoking Cessation Treatment for Methadone Maintenance Patients
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
Timeline
Interventions
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
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily