Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Study Overview
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Brief Summary
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This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.

Official Title
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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Conditions
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Smoking Cessation, Overweight, Obesity

Intervention / Treatment
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* Drug: Nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking 10 or more cigarettes per day Regular access to the internet BMI>=25 Exclusion Criteria: Type I diabetes or Type II diabetes requiring medication Alcohol or drug dependence within the past year Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months Uncontrolled hypertension Severe chronic obstructive pulmonary disease Use of an investigational drug within 30 days or current participation in another clinical trial Current use of tobacco products other than cigarettes or use of marijuana Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment Use of a medication that might affect weight or appetite History of allergic reactions to adhesives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Cognitive Behavioral + Nicotine Patch<br>Cognitive Behavioral Therapy + Nicotine Replacement Patch | Drug: Nicotine patch<br>* Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks<br>* Other names: Nicotine replacement;|
| Active Comparator: Health Education + Nicotine Patch<br>Health Education + Nicotine Replacement Patch | Drug: Nicotine patch<br>* Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks<br>* Other names: Nicotine replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Verified Smoking Cessation (Abstinence) | Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm) | Post-treatment (12-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change | % Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100 | Post-treatment (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Overweight, Obesity, Internet treatment