Tobacco UsePhase 4MESHNCT05277207

Tobacco Cessation Treatment Preferences Among Veteran Smokers

A Phase 4 study testing Personalized Smoking Cessation Facilitation Meetings, Personalized Smoking Cessation Pharmacotherapy and Personalized Text Messaging Support in people with Tobacco Use, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Tobacco Use
What is being tested?: Personalized Smoking Cessation Facilitation Meetings, Personalized Smoking Cessation Pharmacotherapy and Personalized Text Messaging Support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 2 May 2022to 27 Sep 2023
Phase: Phase 4
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

Durham VA patient
willing to complete study procedures
appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months
currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week

Who cannot join

participation in Aim 3 (already received the intervention)
current hospitalization (recent hospitalization is acceptable)
currently not using combustible or smokeless tobacco (vaping only)
acute risk for suicide documented in the medical record
or inability to complete study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875

Other trials in United States

About this study

Official title: Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)

There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.

Read the detailed description

There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers in general cite several prominent barriers to delivering evidence-based tobacco cessation care, including insufficient time, lack of training, a perception of low motivation in their patients, and concerns about the sensitivity of tobacco cessation discussions. In addition, a large proportion of patients who begin tobacco cessation treatment do not achieve initial abstinence. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to personalize treatment has the potential to increase patient engagement and proactively address treatment non-response. The proposed randomized controlled trial is a two-arm experimental design to demonstrate the feasibility of a larger trial and the acceptability of the intervention design. Participants (N = 30) will be stratified by clinic and randomized to either 1) the active treatment, which includes personalized cognitive behavioral treatment, personalized smoking cessation pharmacotherapy, and test messaging support; or 2) standard of care Department of Veterans Affairs' Quitline (telehealth intervention including 5 sessions of CBT) plus SmokefreeVET (text-messaging intervention).

Conditions: Tobacco Use
Being tested: Personalized Smoking Cessation Facilitation Meetings, Personalized Smoking Cessation Pharmacotherapy, Personalized Text Messaging Support, SmokefreeVET, VA Quitline
Keywords: tobacco use, smoking
Medical subject headings: Tobacco Use, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personalized Smoking Cessation Facilitation MeetingsBehavioural
Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation PharmacotherapyDrug
Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging SupportBehavioural
Also called Annie
If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
SmokefreeVETBehavioural
Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA QuitlineBehavioural
Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapyOther
Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.

Study groups in NCT05277207
Study group	Role	What they receive
MESH	Experimental	Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging. Receives: Behavioral: Personalized Smoking Cessation Facilitation Meetings; Drug: Personalized Smoking Cessation Pharmacotherapy; Behavioral: Personalized Text Messaging Support
Best Practice Telehealth Group	Active comparator	Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications. Receives: Behavioral: SmokefreeVET; Behavioral: VA Quitline; Other: Education about pharmacotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Report Post-treatment Satisfaction
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.
Measured: Post-treatment 3-month follow-up visit (approximately three months after enrollment)

Secondary outcomes (3)

Treatment Attendance
Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).
Measured: Post-treatment, approximately eight weeks after baseline visit
Therapist-rated Treatment Acceptability in Active Treatment Group
The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.
Measured: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Proportion of Participants Who Completed Treatment in the Active Treatment Group
The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.
Measured: Post-treatment, approximately eight weeks after baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202227 Sep 2023

First posted14 Mar 2022
Study start2 May 2022
Primary completion27 Sep 2023
Study completion27 Sep 2023

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.
Other trials for Tobacco UseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05277207
Sponsor's protocol ID: CDX 22-005
Acronym: MESH
Status last verified: Apr 2024
First submitted: 2 Mar 2022
Last updated: 7 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: De-identified data sets will be available upon written FOIA request. Final data sets will also be maintained locally until enterprise-level resources become available for broader long-term storage and access unless the relevant ORD or VA Program Office Funding Announcement states otherwise.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Use trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)
ClinicalTrials.gov ID: NCT05277207
Acronym / sponsor ID: MESH / CDX 22-005
Conditions: Tobacco Use
Keywords: tobacco use, smoking
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 2 May 2022 (actual)
Primary completion: 27 Sep 2023 (actual)
Study completion: 27 Sep 2023 (actual)
First posted: 14 Mar 2022 (actual)
Results: Posted 7 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MESH	Experimental	Behavioral: Personalized Smoking Cessation Facilitation Meetings, Drug: Personalized Smoking Cessation Pharmacotherapy, Behavioral: Personalized Text Messaging SupportParticipants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Best Practice Telehealth Group	Active comparator	Behavioral: SmokefreeVET, Behavioral: VA Quitline, Other: Education about pharmacotherapyParticipants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Durham VA patient
willing to complete study procedures
appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months
currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week

Key exclusion criteria (5 listed)

participation in Aim 3 (already received the intervention)
current hospitalization (recent hospitalization is acceptable)
currently not using combustible or smokeless tobacco (vaping only)
acute risk for suicide documented in the medical record
or inability to complete study procedures

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
Personalized Smoking Cessation Facilitation MeetingsParticipants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.	Behavioural	MESH
Personalized Smoking Cessation PharmacotherapyParticipants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.	Drug	MESH
Personalized Text Messaging SupportAlso: AnnieIf the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.	Behavioural	MESH
SmokefreeVETParticipants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.	Behavioural	Best Practice Telehealth Group
VA QuitlineParticipants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.	Behavioural	Best Practice Telehealth Group
Education about pharmacotherapyParticipants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.	Other	Best Practice Telehealth Group

Primary outcome

Number of Participants Who Report Post-treatment Satisfaction
Time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.

3 secondary outcomes

Treatment Attendance
Time frame: Post-treatment, approximately eight weeks after baseline visit
Therapist-rated Treatment Acceptability in Active Treatment Group
Time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Proportion of Participants Who Completed Treatment in the Active Treatment Group
Time frame: Post-treatment, approximately eight weeks after baseline visit

Results and safety

Results posted to the registry on 7 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MESH	15	15
Best Practice Telehealth Group	15	15

Primary outcome: Number of Participants Who Report Post-treatment Satisfaction

Time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment). Count of participants. Unit: Participants

Measure	MESH n = 15	Best Practice Telehealth Group n = 14
Value	15	10

Population analysed: One control participant withdrew prior to the 3-month-follow-up, resulting in 14 control group participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MESH	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Best Practice Telehealth Group	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified data sets will be available upon written FOIA request. Final data sets will also be maintained locally until enterprise-level resources become available for broader long-term storage and access unless the relevant ORD or VA Program Office Funding Announcement states otherwise.

Related trials for Tobacco Use

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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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.

Sarah M. Wilson, 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?

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 4 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 7 May 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2024). 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 Who Report Post-treatment Satisfaction (time frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)). 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 NCT05277207.

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 7 May 2024.