N/A
N=54
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Smoking Cessation · Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01259466 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Number of Participants With Verified Smoking Cessation (Abstinence) — 7; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Verified Smoking Cessation (Abstinence) |
7; 5 | — |
| SECONDARY Percent Weight Change |
1.47; 1.79 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01259466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.