A Trial of Directly Observed and Long-Term Varenicline

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.

Pharmaceutical medication involved
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

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