Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Conditions
Obesity | Overweight | Smoking Cessation
Trial Phase
N/A
Trial Purpose and Description
Trial Purpose
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.
Participation Guidelines
- Age:
- 18 Years - 65 Years
- Gender:
- Both
Eligibility Criteria
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.
- Sponsor:
- American Heart Association
- Yale University
- Dates:
- July 2010
- Last Updated:
- February 5, 2013
- Study HIC#:
- 1001006181
Clinicaltrials.gov ID: NCT01259466


