CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 849 enrolled
Drug / intervention
Practice Quit Attempt plus nicotine lozenge +1 moreother
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/NCT00706979
NCT00706979N/ACompleted

A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers

Medical University of South Carolina·interventional·Posted Jun 30, 2008·Updated Dec 9, 2011

In Brief

A clinical study evaluating Practice Quit Attempt plus nicotine lozenge and Practice Quit Attempt only for Smoking and Smoking Cessation. Completed, enrolled 849 participants.

Detailed Summary

A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions: 1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT). This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period. Our specific hypotheses are as follows: Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up. Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2008
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.0 years ago

Interventions

Practice Quit Attempt plus nicotine lozengeother

nicotine lozenge, 2 mg or 4 mg

Practice Quit Attempt onlybehavioral

Practice Quit Attempts (PQA) message aided by brief advice and self-help materials