Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Overview
- Phase
- Not Applicable
- Intervention
- Nicotine patch
- Conditions
- Smoking Cessation
- Sponsor
- Yale University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Number of Participants With Verified Smoking Cessation (Abstinence)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Marney A. White
Associate Professor of Psychiatry
Yale University
Eligibility Criteria
Inclusion Criteria
- •Smoking 10 or more cigarettes per day
- •Regular access to the internet
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.
Arms & Interventions
Health Education + Nicotine Patch
Health Education + Nicotine Replacement Patch
Intervention: Nicotine patch
Cognitive Behavioral + Nicotine Patch
Cognitive Behavioral Therapy + Nicotine Replacement Patch
Intervention: Nicotine patch
Outcomes
Primary Outcomes
Number of Participants With Verified Smoking Cessation (Abstinence)
Time Frame: Post-treatment (12-weeks)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)
Secondary Outcomes
- Percent Weight Change(Post-treatment (12 weeks))