Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

August 27, 2015 updated by: Marney A. White, Yale University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral + Nicotine Patch
Cognitive Behavioral Therapy + Nicotine Replacement Patch
Drug: Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Other Names:
  • Nicotine replacement
Active Comparator: Health Education + Nicotine Patch
Health Education + Nicotine Replacement Patch
Drug: Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Other Names:
  • Nicotine replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Verified Smoking Cessation (Abstinence)
Time Frame: Post-treatment (12-weeks)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
Post-treatment (12-weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Weight Change
Time Frame: Post-treatment (12 weeks)
% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100
Post-treatment (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Marney A White, PhD, MS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 11, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001006181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Nicotine patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe