Clinical Trial

A Trial of Directly Observed and Long-Term Varenicline

Study Description

A Trial of Directly Observed and Long-term Varenicline

This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessationa?"achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes.


Locations Selected Location


Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Long-Term Varenicline

Varenicline tablet x 24 weeks

Drug - Short-Term Varenicline

varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg tablet

Behavioral - Directly Observed Therapy

Varenicline doses are administered by opioid treatment program nurses

Behavioral - Self Administered Therapy

Varenicline doses are self-administered

Additional Information

Official Study Title

Achieving Smoking Cessation Milestones in Opioid Treatment Patients: a Randomized 2 x 2 Factorial Trial of Directly Observed and Long-term Varenicline

Clinical Trial ID


ParticipAid ID