Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

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.

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Key information

Conditions

Smoking Cessation Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine patch

Drug

Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Other names: Nicotine replacement

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

Time frame: Post-treatment (12 weeks)

% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

American Heart Association

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Dec 14, 2010
Registry last updated: Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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