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

Study Overview
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Brief Summary
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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: Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 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.

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

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Other: Practice Quit Attempt plus nicotine lozenge
* Behavioral: Practice Quit Attempt only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current cigarette smoker of at least 10 cigarettes per day Interested in quitting at some time Not currently interested in quitting smoking Access to telephone (home or work) for 6 month study period 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Practice Quit Attempt plus Nicotine Replacement Therapy | Other: Practice Quit Attempt plus nicotine lozenge<br>* nicotine lozenge, 2 mg or 4 mg<br>* Other names: Nicotine Replacement Therapy (NRT);|
| Active Comparator: 2<br>Practice Quit Attempt only | Behavioral: Practice Quit Attempt only<br>* Practice Quit Attempts (PQA) message aided by brief advice and self-help materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From study enrollment through six month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days |  | 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 |  | At 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smoking cessation, nicotine replacement therapy