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NCT03365362 · ClinicalTrials.gov registry record · Phase 4
A Trial of Directly Observed and Long-term Varenicline
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 243
- Enrollment target
NCT03365362: Completed Phase 4 study, sponsored by Albert Einstein College of Medicine.
NCT03365362 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 243 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03365362, a Phase 4 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 243 participants
- Enrollment target
Study 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.
Primary Outcome
Time-to-initial abstinence, defined as a 24 hour period without smoking, will be assessed as Period of ≥ 24 hour self-reported abstinence during the intervention period, will be assessed. Group mean time-to-initial abstinence will be reported.
Interventions
- BEHAVIORAL Directly Observed Therapy
- DRUG Long-Term Varenicline
- DRUG Short-Term Varenicline
- BEHAVIORAL Self Administered Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2018-10-25 |
| Est. Completion | 2024-04-24 |
| Phase | Phase 4 |
What the finished NCT03365362 record still lists
NCT03365362 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Directly Observed Therapy is the first listed.
NCT03365362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03365362 about?
NCT03365362 is a clinical study titled "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 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic...
What is the current status of trial NCT03365362?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 243 participants. The study started on 2018-10-25. Estimated completion is 2024-04-24.
What interventions are being tested in trial NCT03365362?
The interventions under investigation include: Directly Observed Therapy (BEHAVIORAL), Long-Term Varenicline (DRUG), Short-Term Varenicline (DRUG), Self Administered Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03365362?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03365362's enrollment target sits among peer trials
243 358th of 2000 higher than 1,643 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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