Smoking CessationNCT01001546
Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
A study testing Internet-based and Standard Clinic-Based in people with Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Internet-based and Standard Clinic-Based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in DVAMC for ongoing care
- Served during OEF/OIF
- Current smokers willing to make a quit attempt in the next 30 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Internet-Based Smoking Cessation for OEF/OIF Veterans
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Internet-based, Standard Clinic-Based
- Keywords
- Veterans, Smoking cessation, Operation Enduring Freedom, Operation Iraqi Freedom
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-basedBehavioural
Also called Intervention
Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
Standard Clinic-BasedBehavioural
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Internet-based smoking cessation Receives: Behavioral: Internet-based |
| Arm 2 | Other | Clinic-based smoking cessation Receives: Behavioral: Standard Clinic-Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patrick S. Calhoun, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001546
- Sponsor's protocol ID
- IIR 08-032
- Status last verified
- Dec 2014
- First submitted
- 23 Oct 2009
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22038468Zaborowski 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.
PubMed 21769051Calhoun 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.
PubMed 21523829Straits-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).
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.
PubMed 22338598
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Smoking Cessation for OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT01001546
- Acronym / sponsor ID
- IIR 08-032
- Conditions
- Smoking Cessation
- Keywords
- Veterans, Smoking cessation, Operation Enduring Freedom, Operation Iraqi Freedom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Internet-basedInternet-based smoking cessation |
| Arm 2 | Other | Behavioral: Standard Clinic-BasedClinic-based smoking cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in DVAMC for ongoing care
- Served during OEF/OIF
- Current smokers willing to make a quit attempt in the next 30 days
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-basedAlso: InterventionVeterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. | Behavioural | Arm 1 |
| Standard Clinic-BasedAlso: ControlVeterans 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. | Behavioural | Arm 2 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22038468Gierisch 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.
- Results publication: PubMed 21769051Zaborowski 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.
- Results publication: PubMed 21523829Calhoun 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.
- Results publicationStraits-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).
- Results publication: PubMed 22338598Gierisch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick S. Calhoun, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based and Standard Clinic-Based in people with Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01001546, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.