Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 243 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03365362
The ClinicalTrials.gov registry entry for NCT03365362 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Directly Observed Therapy is the first listed.
NCT03365362 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.