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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

This study is currently recruiting participants.
Verified February 2013 by Yale University
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: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
Overweight
Obesity
 Drug: Nicotine patch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Weight change [ Time Frame: Post-treatment (12 weeks) ] [ Designated as safety issue: No ]
    % Weight change: (pre-treatment weight - post-treatment weight)/ pre-treatment weight


Estimated Enrollment: 84
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Treatment + Nicotine Replacement Drug: Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Active Comparator: Health Education + Nicotine Replacement Drug: Nicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259466

Contacts
Contact: Loren Gianini, PhD 203-737-3473 loren.gianini@yale.edu
Contact: Marney A White, PhD, MS 203-785-4349 marney.white@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Marney A White, PhD, MS            
Sponsors and Collaborators
Yale University
American Heart Association
Investigators
Principal Investigator: Marney A White, PhD, MS Yale University
  More Information

No publications provided

Responsible Party: Marney A. White, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01259466     History of Changes
Other Study ID Numbers: 1001006181
Study First Received: November 11, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Smoking cessation
Overweight
Obesity
Internet treatment

Additional relevant MeSH terms:
Obesity
Smoking
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013