Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Not Applicable

Completed

• Conditions: Overweight; Obesity; Smoking Cessation
• Interventions: Drug: Nicotine patch

• Registration Number: NCT01259466
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-14
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2015-07-16
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-27
• Last Update Submitted: 2015-08-27
• Results First Posted: 2015-09-28
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Smoking 10 or more cigarettes per day
• Regular access to the internet
• BMI>=25

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral + Nicotine Patch	Nicotine patch	Cognitive Behavioral Therapy + Nicotine Replacement Patch
Health Education + Nicotine Patch	Nicotine patch	Health Education + Nicotine Replacement Patch

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Weight Change	Post-treatment (12 weeks)	% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \* 100

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States