Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

NCT ID: NCT01259466

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-11-30

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.

Conditions

Smoking Cessation; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral + Nicotine Patch

Cognitive Behavioral Therapy + Nicotine Replacement Patch

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Health Education + Nicotine Patch

Health Education + Nicotine Replacement Patch

Group Type: ACTIVE_COMPARATOR

Nicotine patch

Intervention Type: DRUG

Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Interventions

Nicotine patch

Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Intervention Type: DRUG

Other Intervention Names

Nicotine replacement

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Marney A. White

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marney A White, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1001006181

Identifier Type: -

Identifier Source: org_study_id