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

Not Applicable

Completed

Interventions: Other: Practice Quit Attempt plus nicotine lozenge
Behavioral: Practice Quit Attempt only

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Monthly cigar, pipe, or smokeless tobacco use
Current pregnancy or breastfeeding
Recent cardiovascular distress
Phenylketonuria (PKU)
Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)

Arm && Interventions

Group	Intervention	Description
1	Practice Quit Attempt plus nicotine lozenge	Practice Quit Attempt plus Nicotine Replacement Therapy
2	Practice Quit Attempt only	Practice Quit Attempt only

Primary Outcome Measures

Name	Time	Method
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	From study enrollment through six month follow-up	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.
A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking	From study enrollment through six month follow-up	Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.

Secondary Outcome Measures