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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Primary Purpose

Smoking Cessation, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking cessation, Overweight, Obesity, Internet treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral + Nicotine Patch

Health Education + Nicotine Patch

Arm Description

Cognitive Behavioral Therapy + Nicotine Replacement Patch

Health Education + Nicotine Replacement Patch

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2010
Last Updated
August 27, 2015
Sponsor
Yale University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01259466
Brief Title
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Official Title
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Overweight, Obesity
Keywords
Smoking cessation, Overweight, Obesity, Internet treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral + Nicotine Patch
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy + Nicotine Replacement Patch
Arm Title
Health Education + Nicotine Patch
Arm Type
Active Comparator
Arm Description
Health Education + Nicotine Replacement Patch
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Other Intervention Name(s)
Nicotine replacement
Intervention Description
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Verified Smoking Cessation (Abstinence)
Description
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
Time Frame
Post-treatment (12-weeks)
Secondary Outcome Measure Information:
Title
Percent Weight Change
Description
% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100
Time Frame
Post-treatment (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marney A White, PhD, MS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

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