NCT01001546

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

October 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 9, 2015

Completed
Last Updated

April 27, 2015

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

October 23, 2009

Results QC Date

January 13, 2015

Last Update Submit

April 6, 2015

Conditions

Smoking Cessation

Keywords

VeteransSmoking cessationOperation Enduring FreedomOperation Iraqi Freedom

Outcome Measures

Primary Outcomes (1)

  • The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)

    3 months post treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Internet-based smoking cessation

Behavioral: Internet-based

Arm 2

OTHER

Clinic-based smoking cessation

Behavioral: Standard Clinic-Based

Interventions

Internet-basedBEHAVIORAL

Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.

Also known as: Intervention
Arm 1
Standard Clinic-BasedBEHAVIORAL

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.

Also known as: Control
Arm 2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

  • Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26.

    PMID: 22038468RESULT

  • Zaborowski DE, Dedert EA, Straits-Troster K, Lee S, Wilson SM, Calhoun PS, Moore SD, Acheson S, Hamlett-Berry KW, Beckham JC. Public health clinical demonstration project for smoking cessation in american veterans who served since september 11, 2001. J Addict Med. 2011 Mar;5(1):79-83. doi: 10.1097/ADM.0b013e3181df97d5.

    PMID: 21769051RESULT

  • Calhoun PS, Levin HF, Dedert EA, Johnson Y; VA Mid-Atlantic Mental Illness Research, Education, Clinical Center Registry Workgroup; Beckham JC. The relationship between posttraumatic stress disorder and smoking outcome expectancies among U.S. military veterans who served since September 11, 2001. J Trauma Stress. 2011 Jun;24(3):303-8. doi: 10.1002/jts.20634. Epub 2011 Apr 26.

    PMID: 21523829RESULT

  • 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).

    RESULT

  • Gierisch JM, Straits-Troster K, Calhoun PS, Beckham JC, Acheson S, Hamlett-Berry K. Tobacco use among Iraq- and Afghanistan-era veterans: a qualitative study of barriers, facilitators, and treatment preferences. Prev Chronic Dis. 2012;9:E58. doi: 10.5888/pcd9.110131. Epub 2012 Feb 16.

    PMID: 22338598RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Patrick S. Calhoun
Organization
Durham VA Medical Center - HSRD
patrick.calhoun2@va.gov
919-286-0411

Study Officials

  • Patrick S. Calhoun, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 26, 2009

Study Start

May 1, 2010

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

April 27, 2015

Results First Posted

March 9, 2015

Record last verified: 2014-12

Locations

US(1)