Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Yale University54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Smoking Cessation Overweight

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With Verified Smoking Cessation (Abstinence)

Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)

Time frame: Post-treatment (12-weeks)

Secondary Outcomes

Percent Weight Change

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

Time frame: Post-treatment (12 weeks)