SmokingNCT02513069
Mobile Contingency Management for Smoking Cessation in Returning US Veterans
A study testing Nicotine gum, mobile contingency management and Telephone counseling in people with Smoking and Veterans, run by Duke University at 1 site in United States.
Trial summary
The primary goal of the study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in promoting smoking abstinence in US Veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Nicotine gum, mobile contingency management and Telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 14 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Smoked at least 10 cigarettes on at least 15 of 30 days before screening
- Served during OEF/OIF/OND era
- Are willing to make a smoking cessation attempt
- Enrolled in the Durham VA for ongoing care
- English speaking
Who cannot join
- Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco
- Active diagnosis of a primary psychotic disorder per medical record
- Are currently imprisoned or in psychiatric hospitalization
- Severely impaired hearing or speech such that telephone counseling is not possible
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
The primary goal of the study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, and smoking cessation medications. The primary aim is to evaluate how effective this intervention is in promoting smoking abstinence compared to telehealth interventions for smoking cessation.
Read the detailed description
Despite recent efforts to expand reach of smoking cessation treatment options beyond clinic based care, smoking cessation treatment including the use of smoking cessation aids remain greatly underutilized. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, there is a fundamental need to develop new and innovative strategies to increase treatment intensity, access, and participation. The use of intensive behavioral therapies, such as contingency management (CM), have demonstrated efficacy for reducing smoking in difficult-to-treat populations, but have had limited reach given the need to verify abstinence multiple times daily via clinic based monitoring. The development of a mobile health (mHealth) platform to provide CM has made the use of intensive CM approaches portable and feasible. The primary goal of the current study is to evaluate the effectiveness of a proactive tele-health intervention that combines evidenced based treatment for smoking cessation with smartphone based, portable contingency management on smoking rates. The central hypothesis is that increasing the intensity of available tele-health smoking approaches through the addition of mobile CM will be an effective way to reduce smoking rates in Veterans returning from the Iraq/Afghanistan wars. Guided by strong preliminary data, this hypothesis will be tested in a comparative effectiveness trial with a two-group design in which 260 Veteran smokers will be randomized to receive either an "mCM" intervention which combines evidence-based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mCM administered through a smart phone or to a control condition that will provide controls for therapist, medication, time and attention effects. Specific aims are to evaluate (1) the impact of mCM on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at 3-month, 6-month, and 12 month post-randomization follow-up, (2) the relative cost-effectiveness of the mCM intervention in quality adjusted life years (QALY), and (3) potential treatment mediators including self-efficacy and treatment process mechanisms. The approach is innovative because it builds upon advances in mHealth technology and will be the first evaluation of smart phone based mobile CM in conjunction with other evidence-based smoking cessation treatment for OEF/OIF/OND Veterans. There is a surprising lack of research aimed at evaluating multi-component smoking cessation interventions that integrate CM with evidence-based cognitive-behavioral treatment and smoking cessation aids such as NRT. Cigarette smoking remains the most lethal substance use disorder in the United States and military veterans are at particular high risk for smoking related morbidity and mortality. The significance of identifying cost-effective approaches to decreasing tobacco use in the relatively young and at-risk cohort of returning Veterans could be tremendous as it will prevent significant morbidity and mortality.
- Being tested
- Nicotine gum, mobile contingency management, Telephone counseling, Nicotine patch, Nicotine lozenge
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine gumOther
Also called nicotine polacrilex
Participants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine gum as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings.
mobile contingency managementBehavioural
Also called mCM
Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided reinforcement for videos that suggest smoking abstinence.
Telephone counselingBehavioural
Also called CBT for smoking cessation
Participants receive five sessions of cognitive-behavioral telephone counseling, and a participant manual. The telephone counseling protocol included in this application is based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation and is informed by behavioral treatment principles .
Nicotine patchOther
Also called Nicoderm
Participants will be prescribed nicotine patches to be used during the post-quit phase of the study.
Nicotine lozengeOther
Participants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine lozenge as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings.
Smart phoneOther
Participants in the experimental condition will be loaned a smart phone to use during the mobile contingency management intervention period. The phone will be used to record videos of carbon monoxide readings to determine smoking abstinence.
Carbon monoxide monitorOther
Also called CO monitor
Participants in the experimental condition will be loaned a CO monitor to use during the mobile contingency management intervention period. The monitor will be used to determine carbon monoxide content in the breath as a measurement of smoking.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Contingency Management (mCM) | Experimental | The mCM arm represents a proactive tele-health intervention that combines guideline based cognitive-behavioral smoking cessation telephone counseling, a tele-medicine clinic for access to nicotine replacement therapy (NRT), and intensive behavioral therapy administered via a smart phone (with carbon monoxide monitor) based application. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date. Receives: Other: Nicotine gum; Behavioral: mobile contingency management; Behavioral: Telephone counseling; Other: Nicotine patch; Other: Nicotine lozenge; Other: Smart phone; Other: Carbon monoxide monitor |
| Tele-Health for Smoking Ccessation | Active comparator | TELE-HEALTH FOR SMOKING CESSATION is 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, and tele-medicine clinic for access to NRT as in the mCM intervention. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date. Receives: Other: Nicotine gum; Behavioral: Telephone counseling; Other: Nicotine patch; Other: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking, self-report
Participants' self-report of smoking in the past seven days will be measured at 6-month follow-up study visit.
Measured: 6 month follow-up (6 months post-quit attempt)
Secondary outcomes (5)
saliva cotinine
For participants reporting smoking abstinence at 6-months post treatment follow-up, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels.
Measured: 6 month follow-up (6 months post-quit attempt)
smoking, self-report
Participants' self-report of smoking in the past seven days will be measured at approximately eight weeks after the participant's initial smoking quit attempt.
Measured: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
saliva cotinine
For participants reporting smoking abstinence eight weeks after their smoking quit attempt, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels.
Measured: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
smoking, self-report
Participants' self-report of smoking in the past seven days will be measured at 3-month follow-up study visit.
Measured: 3 month follow-up (3 months post-quit attempt)
saliva cotinine
For participants reporting smoking abstinence at the 3-month follow-up contact, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels.
Measured: 3 month follow-up (3 months post-quit attempt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJan 2015
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Durham VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Patrick S Calhoun, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513069
- Sponsor's protocol ID
- Pro00050835
- Status last verified
- Feb 2020
- First submitted
- 28 Jul 2015
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Contingency Management for Smoking Cessation in Returning US Veterans
- ClinicalTrials.gov ID
- NCT02513069
- Acronym / sponsor ID
- Pro00050835
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Durham VA Medical Center
- Study start
- Jan 2015
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, and smoking cessation medications. The primary aim is to evaluate how effective this intervention is in promoting smoking abstinence compared to telehealth interventions for smoking cessation.
Detailed description
Despite recent efforts to expand reach of smoking cessation treatment options beyond clinic based care, smoking cessation treatment including the use of smoking cessation aids remain greatly underutilized. If cessation programs are to have significant impact (Impact = Reach X Efficacy) on changing health behavior at the population level, there is a fundamental need to develop new and innovative strategies to increase treatment intensity, access, and participation. The use of intensive behavioral therapies, such as contingency management (CM), have demonstrated efficacy for reducing smoking in difficult-to-treat populations, but have had limited reach given the need to verify abstinence multiple times daily via clinic based monitoring. The development of a mobile health (mHealth) platform to provide CM has made the use of intensive CM approaches portable and feasible. The primary goal of the current study is to evaluate the effectiveness of a proactive tele-health intervention that combines evidenced based treatment for smoking cessation with smartphone based, portable contingency management on smoking rates. The central hypothesis is that increasing the intensity of available tele-health smoking approaches through the addition of mobile CM will be an effective way to reduce smoking rates in Veterans returning from the Iraq/Afghanistan wars. Guided by strong preliminary data, this hypothesis will be tested in a comparative effectiveness trial with a two-group design in which 260 Veteran smokers will be randomized to receive either an "mCM" intervention which combines evidence-based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mCM administered through a smart phone or to a control condition that will provide controls for therapist, medication, time and attention effects. Specific aims are to evaluate (1) the impact of mCM on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at 3-month, 6-month, and 12 month post-randomization follow-up, (2) the relative cost-effectiveness of the mCM intervention in quality adjusted life years (QALY), and (3) potential treatment mediators including self-efficacy and treatment process mechanisms. The approach is innovative because it builds upon advances in mHealth technology and will be the first evaluation of smart phone based mobile CM in conjunction with other evidence-based smoking cessation treatment for OEF/OIF/OND Veterans. There is a surprising lack of research aimed at evaluating multi-component smoking cessation interventions that integrate CM with evidence-based cognitive-behavioral treatment and smoking cessation aids such as NRT. Cigarette smoking remains the most lethal substance use disorder in the United States and military veterans are at particular high risk for smoking related morbidity and mortality. The significance of identifying cost-effective approaches to decreasing tobacco use in the relatively young and at-risk cohort of returning Veterans could be tremendous as it will prevent significant morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Contingency Management (mCM) | Experimental | Other: Nicotine gum, Behavioral: mobile contingency management, Behavioral: Telephone counseling, Other: Nicotine patch, Other: Nicotine lozenge, Other: Smart phone, Other: Carbon monoxide monitorThe mCM arm represents a proactive tele-health intervention that combines guideline based cognitive-behavioral smoking cessation telephone counseling, a tele-medicine clinic for access to nicotine replacement therapy (NRT), and intensive behavioral therapy administered via a smart phone (with carbon monoxide monitor) based application. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date. |
| Tele-Health for Smoking Ccessation | Active comparator | Other: Nicotine gum, Behavioral: Telephone counseling, Other: Nicotine patch, Other: Nicotine lozengeTELE-HEALTH FOR SMOKING CESSATION is 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, and tele-medicine clinic for access to NRT as in the mCM intervention. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smoked at least 10 cigarettes on at least 15 of 30 days before screening
- Served during OEF/OIF/OND era
- Are willing to make a smoking cessation attempt
- Enrolled in the Durham VA for ongoing care
- English speaking
Key exclusion criteria (4 listed)
- Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco
- Active diagnosis of a primary psychotic disorder per medical record
- Are currently imprisoned or in psychiatric hospitalization
- Severely impaired hearing or speech such that telephone counseling is not possible
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 |
|---|---|---|
| Nicotine gumAlso: nicotine polacrilexParticipants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine gum as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings. | Other | Mobile Contingency Management (mCM), Tele-Health for Smoking Ccessation |
| mobile contingency managementAlso: mCMParticipants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided reinforcement for videos that suggest smoking abstinence. | Behavioural | Mobile Contingency Management (mCM) |
| Telephone counselingAlso: CBT for smoking cessationParticipants receive five sessions of cognitive-behavioral telephone counseling, and a participant manual. The telephone counseling protocol included in this application is based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation and is informed by behavioral treatment principles . | Behavioural | Mobile Contingency Management (mCM), Tele-Health for Smoking Ccessation |
| Nicotine patchAlso: NicodermParticipants will be prescribed nicotine patches to be used during the post-quit phase of the study. | Other | Mobile Contingency Management (mCM), Tele-Health for Smoking Ccessation |
| Nicotine lozengeParticipants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine lozenge as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings. | Other | Mobile Contingency Management (mCM), Tele-Health for Smoking Ccessation |
| Smart phoneParticipants in the experimental condition will be loaned a smart phone to use during the mobile contingency management intervention period. The phone will be used to record videos of carbon monoxide readings to determine smoking abstinence. | Other | Mobile Contingency Management (mCM) |
| Carbon monoxide monitorAlso: CO monitorParticipants in the experimental condition will be loaned a CO monitor to use during the mobile contingency management intervention period. The monitor will be used to determine carbon monoxide content in the breath as a measurement of smoking. | Other | Mobile Contingency Management (mCM) |
Primary outcome
smoking, self-report
Time frame: 6 month follow-up (6 months post-quit attempt)
Participants' self-report of smoking in the past seven days will be measured at 6-month follow-up study visit.
5 secondary outcomes
saliva cotinine
Time frame: 6 month follow-up (6 months post-quit attempt)
smoking, self-report
Time frame: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
saliva cotinine
Time frame: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
smoking, self-report
Time frame: 3 month follow-up (3 months post-quit attempt)
saliva cotinine
Time frame: 3 month follow-up (3 months post-quit attempt)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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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, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine gum, mobile contingency management and Telephone counseling in people with Smoking and Veterans, run by Duke University 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 5 inclusion and 4 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 21 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
smoking, self-report (time frame: 6 month follow-up (6 months post-quit attempt)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2020.