N/A N=100 Randomized Treatment

Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Tobacco Use Disorder · Medication Adherence

Bottom Line

View on ClinicalTrials.gov: NCT01378858 ↗

Enrolled (actual)

100

Serious AEs

5.0%

Results posted

Mar 2021

Primary outcome: Primary: Varenicline Adherence as Measured by Pill Count — 61.8; 78.5 percentage pills taken/pills dispensed

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Varenicline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Varenicline Adherence as Measured by Pill Count	61.8; 78.5	—
SECONDARY Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks	9; 5	—
SECONDARY Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks	6; 2	—

Summary

This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
English speaking
Smoked at least 100 cigarettes/lifetime
Smoke 5 or more cigarettes per day
Interested in quitting smoking (preparation or contemplation stage of change)
Enrolled in Einstein/Montefiore methadone program for 12 weeks or more
Receiving methadone in clinic three, four, five or six times per week
No more than 2 methadone clinic misses in prior 14 days
Agree to use contraception for the duration of the trial (among women with reproductive potential)
Willing to participate in all study components
Able to provide informed consent

Exclusion Criteria

Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
Psychiatric instability
Women who are pregnant, breastfeeding, or contemplating pregnancy
Creatinine clearance <30 mL/min

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01378858). 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.