CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 320 enrolled
Drug / intervention
Nicotinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01702532
NCT01702532Phase 3Completed

A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge

GlaxoSmithKline·interventional·Posted Oct 8, 2012·Updated Jan 30, 2014

In Brief

A Phase 3 clinical trial evaluating Nicotine for Smoking Cessation. Completed, enrolled 320 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2012
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.7 years ago

Interventions

Nicotinedrug

Comparison of different dosage forms of nicotine