Tobacco Intervention in Primary Care Treatment Opportunities for Providers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of sampling of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.

Official Title
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Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Other: Nicotine Replacement Therapy (NRT) Sampling
* Behavioral: Ask, Advise, Refer (physician brief advice)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >=18 daily (25+ days within past 30) cigarette smoker of >5 cigs/day English speaking recruited through primary care sites aligned with study Exclusion Criteria: - no FDA contraindications for use of NRT: not pregnant, breastfeeding, or planning to become pregnant no recent (past 3 months) cardiovascular trauma: MI, stroke

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Replacement Therapy (NRT)<br>2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch | Other: Nicotine Replacement Therapy (NRT) Sampling<br>* 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch<br>|
| Active Comparator: Ask, Advise, Refer (physician brief advice)<br>Ask, Advise, Refer (physician brief advice) | Behavioral: Ask, Advise, Refer (physician brief advice)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence |  | From study enrollment through end of six-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Self-defined Attempt to Stop Smoking Cigarettes |  | From study enrollment through end of six-month follow up | 
| Use of Any Smoking Cessation Medication |  | From study enrollment through end of six-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, primary care, comparative effectiveness