Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Obesity Clinical Trial

Official title:

Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259466
• Other study ID #: 1001006181
• Status: Completed
• Phase: N/A
• First received: November 11, 2010
• Last updated: August 27, 2015
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: August 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Smoking Cessation

Intervention

Drug:
• Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Post-treatment (12-weeks)	No
Secondary	Percent Weight Change	% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100	Post-treatment (12 weeks)	No