Clinical trial NCT01259466: Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Official title: Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Overweight
Obesity
Keywords: Smoking cessation
Overweight
Obesity
Internet treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2010-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Verified Smoking Cessation (Abstinence)
timeFrame: Post-treatment (12-weeks)
Secondary outcomes:
measure: Percent Weight Change
timeFrame: Post-treatment (12 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Marney A White, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: