A Trial of Directly Observed and Long-term Varenicline
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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
cessation-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.
Phase:
Phase 4
Details
Lead Sponsor:
Albert Einstein College of Medicine
Collaborators:
National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH) Pfizer