VeteranNCT01723163
Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
A study testing Abstinence Reinforcement Therapy (ART) and Telephone Counseling and NRT in people with Veteran and Smoking Cessation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The primary goal of the current study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that investigators are calling Abstinence Reinforcement Therapy (ART). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Veteran, Smoking Cessation
- What is being tested?
- Abstinence Reinforcement Therapy (ART) and Telephone Counseling and NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2013to Sep 2017
- 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 the Durham VA for ongoing care.
- Current smokers planning to quit smoking in the next 30 days.
Who cannot join
- Active diagnosis of psychosis documented 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).
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
The primary goal of the current study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and intensive behavioral therapy through mobile contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same guideline based cognitive-behavioral smoking cessation telephone counseling (TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Read the detailed description
The addition of contingency management (CM) to existing evidenced-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent upon objective evidence of abstinence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily with a clinic based carbon monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient and day treatment programs. The application of emerging smart-phone technology, however, can overcome this barrier. Investigators have developed a smart-phone application which allows a participant to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server. This innovation has made the use of CM for outpatient smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the current study is to evaluate the effectiveness of a combined tele-health and CM intervention that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and intensive behavioral therapy through mobile contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same guideline based cognitive-behavioral smoking cessation telephone counseling (TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Both of the proposed interventions are designed in accordance with national smoking cessation guidelines. Tele-health smoking cessation interventions are typically less intensive than clinic based specialty care, but increase reach of services through bypassing barriers to participation such as geographical distance from VA care. The addition of mCM to an evidence-based tele-health smoking intervention will significantly increase the intensity of the intervention and is predicted to increase efficacy. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, investigators must identify new and innovative strategies to increase treatment intensity, access, and participation.
The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at 3-month, 6-month, and 12-month post-randomization follow-ups.
Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART-based intervention than those randomized to the Tele-health alone intervention (primary end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).
- Conditions
- Veteran, Smoking Cessation
- Being tested
- Abstinence Reinforcement Therapy (ART), Telephone Counseling and NRT
- Keywords
- veteran, smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence Reinforcement Therapy (ART)Behavioural
Also called Intervention
Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
Telephone Counseling and NRTBehavioural
Also called Control
Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Abstinence Reinforcement Therapy (ART) Receives: Behavioral: Abstinence Reinforcement Therapy (ART) |
| Control | Other | Telephone Counseling Receives: Behavioral: Telephone Counseling and NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.
Measured: 6-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study start21 Nov 2013
- Primary completion15 Dec 2016
- Study completionSep 2017
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 (4)Papers the sponsor has linked to this study.
- Other trials for VeteranStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- 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
- NCT01723163
- Sponsor's protocol ID
- IIR 12-365
- Status last verified
- Oct 2018
- First submitted
- 5 Nov 2012
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10.
PubMed 27521811Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh.2016.03.004. Epub 2016 Mar 11.
PubMed 27046670Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
PubMed 28340108Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup; Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14.
PubMed 28808856
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
- ClinicalTrials.gov ID
- NCT01723163
- Acronym / sponsor ID
- IIR 12-365
- Conditions
- Veteran, Smoking Cessation
- Keywords
- veteran, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the current study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and intensive behavioral therapy through mobile contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same guideline based cognitive-behavioral smoking cessation telephone counseling (TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Detailed description
The addition of contingency management (CM) to existing evidenced-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent upon objective evidence of abstinence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily with a clinic based carbon monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient and day treatment programs. The application of emerging smart-phone technology, however, can overcome this barrier. Investigators have developed a smart-phone application which allows a participant to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server. This innovation has made the use of CM for outpatient smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the current study is to evaluate the effectiveness of a combined tele-health and CM intervention that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and intensive behavioral therapy through mobile contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same guideline based cognitive-behavioral smoking cessation telephone counseling (TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Both of the proposed interventions are designed in accordance with national smoking cessation guidelines. Tele-health smoking cessation interventions are typically less intensive than clinic based specialty care, but increase reach of services through bypassing barriers to participation such as geographical distance from VA care. The addition of mCM to an evidence-based tele-health smoking intervention will significantly increase the intensity of the intervention and is predicted to increase efficacy. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, investigators must identify new and innovative strategies to increase treatment intensity, access, and participation.
The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at 3-month, 6-month, and 12-month post-randomization follow-ups.
Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART-based intervention than those randomized to the Tele-health alone intervention (primary end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Abstinence Reinforcement Therapy (ART)Abstinence Reinforcement Therapy (ART) |
| Control | Other | Behavioral: Telephone Counseling and NRTTelephone Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in the Durham VA for ongoing care.
- Current smokers planning to quit smoking in the next 30 days.
Key exclusion criteria (3 listed)
- Active diagnosis of psychosis documented 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).
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 |
|---|---|---|
| Abstinence Reinforcement Therapy (ART)Also: InterventionVeterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) | Behavioural | Intervention |
| Telephone Counseling and NRTAlso: ControlVeterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT) | Behavioural | Control |
Primary outcome
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Time frame: 6-month post-treatment
Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27521811Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10.
- Results publication: PubMed 27046670Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh.2016.03.004. Epub 2016 Mar 11.
- Results publication: PubMed 28340108Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
- Results publication: PubMed 28808856Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup; Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14.
- Individual participant dataSharing planned: Undecided
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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 Abstinence Reinforcement Therapy (ART) and Telephone Counseling and NRT in people with Veteran and Smoking Cessation, run by VA Office of Research and Development 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 2 inclusion and 3 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 1 Mar 2019. 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 1 Mar 2019). 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?
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up (time frame: 6-month 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 NCT01723163, which also lists 4 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 1 Mar 2019.