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Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

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Yale University

Status

Completed

Conditions

Overweight
Obesity
Smoking Cessation

Treatments

Drug: Nicotine patch

Study type

Interventional

Funder types

Other

Identifiers

NCT01259466
1001006181

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Cognitive Behavioral + Nicotine Patch
Experimental group
Description:
Cognitive Behavioral Therapy + Nicotine Replacement Patch
Treatment:
Drug: Nicotine patch
Health Education + Nicotine Patch
Active Comparator group
Description:
Health Education + Nicotine Replacement Patch
Treatment:
Drug: Nicotine patch

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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