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NCT01702532 · ClinicalTrials.gov registry record · Phase 3
Nicotine Mouth Film for Craving Relief.
A Phase 3 study of Smoking Cessation, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
- 2
- Study locations
NCT01702532: Completed Phase 3 study of Smoking Cessation, sponsored by GlaxoSmithKline.
NCT01702532 is a Phase 3 study of Smoking Cessation that has completed, run by GlaxoSmithKline. The registered enrollment target is 320 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01702532, a Phase 3 study of Smoking Cessation, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
- 2
- Study locations
Study Summary
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.
Primary Outcome
Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving
Conditions Studied
Interventions
- DRUG Nicotine
Study Locations (2)
California
- Los Angeles Clinical Trials - Burbank
Kentucky
- Central Kentucky Research Associates, Inc. - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01702532 record still lists
NCT01702532 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 1 intervention - of which Nicotine is the first listed.
NCT01702532 reports a single indexed study location in California, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01702532 about?
NCT01702532 is a clinical study titled "Nicotine Mouth Film for Craving Relief.". Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provo...
What is the current status of trial NCT01702532?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2012-09. Estimated completion is 2012-12.
What conditions does trial NCT01702532 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT01702532?
The interventions under investigation include: Nicotine (DRUG).
Who is sponsoring clinical trial NCT01702532?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01702532 being conducted?
This trial has 2 study locations across California, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01702532's enrollment target sits among peer trials
320 75th of 188 higher than 114 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation 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.
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