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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
849
nicotine lozenge, 2 mg or 4 mg
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.
Time frame: From study enrollment through six month follow-up
A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.
Time frame: From study enrollment through six month follow-up
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time frame: At any point during the study
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time frame: At 6-month follow-up
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