drugset / Trial / NCT03365362
A Trial of Directly Observed and Long-term Varenicline
Phase 4
Completed
243 enrolled
Albert Einstein College of Medicine
National Institute on Drug Abuse (NIDA) · collabNational Institutes of Health (NIH) · collabPfizer · collab
RandomizedFactorialTriple-blindTreatment
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 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.
Timeline
- Start
- 2018-10-25
- Primary completion
- 2023-11-14
- Completion
- 2024-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varenicline | Small molecule | 1 mg | — |