NCT01259466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 28, 2015

Completed
Last Updated

September 28, 2015

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

November 11, 2010

Results QC Date

July 16, 2015

Last Update Submit

August 27, 2015

Conditions

Smoking CessationOverweightObesity

Keywords

Smoking cessationOverweightObesityInternet treatment

Outcome Measures

Primary Outcomes (1)

  • 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)

    Post-treatment (12-weeks)

Secondary Outcomes (1)

  • Percent Weight Change

    Post-treatment (12 weeks)

Study Arms (2)

Cognitive Behavioral + Nicotine Patch

EXPERIMENTAL

Cognitive Behavioral Therapy + Nicotine Replacement Patch

Drug: Nicotine patch

Health Education + Nicotine Patch

ACTIVE COMPARATOR

Health Education + Nicotine Replacement Patch

Drug: Nicotine patch

Interventions

Nicotine patchDRUG

Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Also known as: Nicotine replacement
Cognitive Behavioral + Nicotine PatchHealth Education + Nicotine Patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking 10 or more cigarettes per day
  • Regular access to the internet
  • BMI\>=25

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Smoking CessationOverweightObesity

Interventions

Tobacco Use Cessation DevicesNicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDrug Therapy

Results Point of Contact

Title
Dr. Marney A. White
Organization
Yale University School of Medicine
marney.white@yale.edu
203-785-4349

Study Officials

  • Marney A White, PhD, MS

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

November 11, 2010

First Posted

December 14, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 28, 2015

Results First Posted

September 28, 2015

Record last verified: 2015-08

Locations

US(1)