Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

Completed · Not applicable

Conditions studied: Tobacco Use Disorder, Medication Adherence

In brief

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.

Key facts

Study ID

NCT01378858

Run by

Albert Einstein College of Medicine

People needed

100

Starts

2011-07-01

Expected to finish

2015-07-01

Last updated by the study team

2021-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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