drugset / Trial / NCT01027754

Smoking Cessation Treatment for Methadone Maintenance Patients

NCT01027754 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-08
Primary completion
2011-09
Completion
2011-09

Outcome

Met primary endpoint

paper Subjects receiving varenicline were more likely than those receiving placebo to achieve abstinence (10.5 versus 0%, P = 0.03 PMID 24862167 ↗

registry Varenicline vs Placebo; p = 0.03; Fisher Exact NCT01027754 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 1 mg —