Smoking Cessation Clinical Trial
Official title:
A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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