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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Marney A. White, Yale University
ClinicalTrials.gov Identifier:
NCT01259466
First received: November 11, 2010
Last updated: August 27, 2015
Last verified: August 2015

November 11, 2010
August 27, 2015
July 2010
November 2013   (final data collection date for primary outcome measure)
Number of Participants With Verified Smoking Cessation (Abstinence) [ Time Frame: Post-treatment (12-weeks) ] [ Designated as safety issue: No ]
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
Smoking cessation (abstinence) [ Time Frame: Post-treatment (12-weeks) ] [ Designated as safety issue: No ]
Continuous abstinence during the last 28 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
Complete list of historical versions of study NCT01259466 on ClinicalTrials.gov Archive Site
Percent Weight Change [ Time Frame: Post-treatment (12 weeks) ] [ Designated as safety issue: No ]
% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100
Weight change [ Time Frame: Post-treatment (12 weeks) ] [ Designated as safety issue: No ]
% Weight change: (pre-treatment weight - post-treatment weight)/ pre-treatment weight
Not Provided
Not Provided
 
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking Cessation
  • Overweight
  • Obesity
Drug: Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Other Name: Nicotine replacement
  • Experimental: Cognitive Behavioral + Nicotine Patch
    Cognitive Behavioral Therapy + Nicotine Replacement Patch
    Intervention: Drug: Nicotine patch
  • Active Comparator: Health Education + Nicotine Patch
    Health Education + Nicotine Replacement Patch
    Intervention: Drug: Nicotine patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01259466
1001006181
No
Not Provided
Not Provided
Marney A. White, Yale University
Yale University
American Heart Association
Principal Investigator: Marney A White, PhD, MS Yale University
Yale University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP