Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001546
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : March 9, 2015
Last Update Posted : April 27, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The overarching aim of the study is to evaluate in a randomized trial the impact of an internet intervention compared to a standard clinic-based control group to promote smoking cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Internet-based Behavioral: Standard Clinic-Based Not Applicable

Detailed Description:

Project Background: Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Intensive speciality clinic-based tobacco cessation programs have high efficacy, are more cost effective than less intensive approaches, and are employed by most VA medical centers. These programs, however, are infrequently attended by veterans, limiting the impact on prevalence, disease burden, and economic costs of smoking. An internet-based smoking cessation intervention could be an effective, low-cost method to implement evidence based smoking cessation principles. The internet could significantly increase the impact of smoking cessation efforts over current approaches by avoiding barriers that limit utilization of existing clinic-based services.

Project Objectives: The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans. Accordingly, the specific aims and hypotheses are:

AIM 1: To evaluate the impact of an internet-based smoking cessation intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 3 months and 12-month post-treatment follow-ups.

Hypothesis 1: Abstinence rates will be significantly higher among veterans randomized to the web-based intervention than those randomized to VA specialty cessation care.

AIM 2: To evaluate the impact of an internet-based smoking cessation intervention on reach of smoking cessation treatment.

Hypothesis 2.1: Internet-based treatment will result in increased reach as measured by the proportion of patients who access care. Hypothesis 2.2: Internet-based treatment will result in engagement in treatment as measured by the proportion of patients that make at least one quit attempt.

AIM 3: To evaluate the relative cost-effectiveness of the standard specialty care intervention to the web-based intervention.

Project Methods: Proposed is a trial in which 410 OEF/OIF veteran smokers will be randomized to receive either an internet-based smoking cessation intervention and nicotine replacement therapy or referral to VA specialty smoking cessation care, which includes behavioral therapy, group counseling, telephone counseling, self-help materials, and choice of smoking cessation aid (pharmacotherapy).

Participating patients will be surveyed at 3 months post-intervention and at 12 months. The primary outcome of the trial is a 7-day point prevalence abstinence at the 3-month post intervention follow-up, as measured by self-report and verified by cotinine assay.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-Based Smoking Cessation for OEF/OIF Veterans
Study Start Date : May 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
Internet-based smoking cessation
Behavioral: Internet-based
Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
Other Name: Intervention

Arm 2
Clinic-based smoking cessation
Behavioral: Standard Clinic-Based
Veterans randomized to the control condition will have a consult placed to the Durham VA Medical Center (DVAMC) specialty Smoking Cessation Clinic placed on their behalf.
Other Name: Control

Primary Outcome Measures :
  1. The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) [ Time Frame: 3 months post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Enrolled in DVAMC for ongoing care
  • Served during OEF/OIF
  • Current smokers willing to make a quit attempt in the next 30 days

Exclusion Criteria:

  • Active diagnosis of psychosis in the medical record
  • Diagnosis of severe dementia in the medical record
  • Does not have access to a telephone
  • Severely impaired hearing or speech (veterans must be able to respond to phone calls)
  • Refusal to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001546

United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Patrick S. Calhoun, PhD Durham VA Medical Center, Durham, NC

Publications of Results:
Straits-Troster K, Acheson S, Beckham JC, Calhoun PS, Gierisch JM, Hamlett-Berry K. Tobacco use and cessation among returning combat veterans: A mixed methods study. [Abstract]. Behavioral medicine update : a publication of the Society of Behavioral Medicine. 2010 Apr 10; 39(S1).

Responsible Party: VA Office of Research and Development Identifier: NCT01001546     History of Changes
Other Study ID Numbers: IIR 08-032
First Posted: October 26, 2009    Key Record Dates
Results First Posted: March 9, 2015
Last Update Posted: April 27, 2015
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
Smoking cessation
Operation Enduring Freedom
Operation Iraqi Freedom