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NCT01772641 · ClinicalTrials.gov registry record · Phase 4
A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT01772641: Clinical Trial Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01772641 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772641, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.
Primary Outcome
Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
Interventions
- OTHER Scheduled Gradual Reduction + Varenicline
- OTHER Scheduled Gradual Reduction + Placebo Drug
- OTHER Basic Advice + Varenicline
- OTHER Basic Advice + Placebo Drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
Why NCT01772641 stopped before completion
NCT01772641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Scheduled Gradual Reduction + Varenicline is the first listed.
NCT01772641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01772641 about?
NCT01772641 is a clinical study titled "A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation". This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that S...
What is the current status of trial NCT01772641?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2012-12. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01772641?
The interventions under investigation include: Scheduled Gradual Reduction + Varenicline (OTHER), Scheduled Gradual Reduction + Placebo Drug (OTHER), Basic Advice + Varenicline (OTHER), Basic Advice + Placebo Drug (OTHER).
Who is sponsoring clinical trial NCT01772641?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01772641's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 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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