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