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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 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.

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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.

Interventions

  • OTHER Scheduled Gradual Reduction + Varenicline
  • OTHER Scheduled Gradual Reduction + Placebo Drug
  • OTHER Basic Advice + Varenicline
  • OTHER Basic Advice + Placebo Drug

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2012-12
Est. Completion 2014-01
Phase Phase 4

What the Registry Record Tells You About NCT01772641

The ClinicalTrials.gov registry entry for NCT01772641 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Scheduled Gradual Reduction + Varenicline is the first listed.

NCT01772641 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.