Tobacco Use DisorderPhase 2TMS-STOPNCT05723588
Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
A Phase 2 study testing active repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation and nicotine replacement therapy in people with Tobacco Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- active repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation and nicotine replacement therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a US Veteran
- Meets DSM-5 criteria for tobacco use disorder
- Is between the ages of 18 and 75
- Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppm
- Is willing to attempt smoking cessation
- Meets DSM-5 criteria for current PTSD diagnosis
Show all 9Show fewer
- Speaks, reads and writes English
- Is willing to sign a Duke consent for those portions of the study that occur at Duke
- Has been stable on psychotropic medications for at least three months
Who cannot join
- Has had a substance use disorder other than tobacco in the preceding 3 months
- Has a history of myocardial infarction in the past 6 months or has another contraindication to NRT
- Has a contraindication to TMS or MRI
- Personal or family history of a seizures or epilepsy
- History of neurological condition that increases the risk of seizures including stroke or transient ischemic attack, cerebral aneurysm, or severe traumatic brain injury from a penetrating head injury, loss of consciousness > 20 minutes at time of traumatic injury, requiring an anticonvulsant medication for seizures, and/or found to have encephalomalacia on baseline MRI
- Structural brain lesion, or prior brain surgery
Show all 16Show fewer
- Ferromagnetic metal in head (including shrapnel)
- Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator)
- Is pregnant (to be determined at Duke)
- Is unable to complete study procedures
- Is currently prescribed bupropion and/or varenicline
- Uses other forms of nicotine such as cigars, pipes, chewing tobacco, or vaping
- Is unable to provide informed consent due to a major neurocognitive disorder or other reason
- Meets criteria for a primary psychotic disorder or current manic episode
- Is currently imprisoned or psychiatrically hospitalized
- Has previously received rTMS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Susanna B Oberg, AAS AAS, 615-873-6955, susanna.oberg@va.gov
Jonathan R Young, MD
About this study
Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. This project seeks to evaluate the feasibility and effectiveness of a smoking cessation treatment for Veterans with posttraumatic stress disorder (PTSD) who smoke. The treatment combines smoking cessation counseling, nicotine replacement therapy (e.g., nicotine gum), and repetitive transcranial magnetic stimulation (rTMS). rTMS is a noninvasive brain stimulation treatment that has been cleared by the Food and Drug Administration for smoking cessation in adults.
Read the detailed description
Tobacco use remains the number one preventable cause of death in the United States. Unfortunately, individuals with mental health conditions are disproportionately affected. Tobacco use is also high among US Veterans, and those who have experienced trauma are even more likely to smoke. Successful quitting is especially difficult for individuals who develop posttraumatic stress disorder (PTSD). Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Neuroimaging techniques such as resting-state functional magnetic resonance imaging (rs-fMRI) have provided insight into the neurocircuitry of tobacco use disorder (TUD) and successful quit attempts. Interventions that modulate the neural systems underlying TUD, such as repetitive transcranial magnetic stimulation (rTMS), may be critical to improving clinical outcomes. Indeed, the US Food and Drug Administration (FDA) recently cleared a form of rTMS as a short-term smoking cessation treatment in adults. However, most clinical trials on rTMS for smoking cessation have been conducted in civilian samples and have excluded individuals with psychiatric conditions. To improve smoking cessation treatment options for Veterans with PTSD, it is critical to evaluate novel brain stimulation methods such as rTMS in this vulnerable population. Furthermore, the development of neuroscience-informed techniques to enhance rTMS such as neuronavigation based on rs-fMRI is critical to individualizing rTMS for smoking cessation and understanding mechanisms of action. The application of neuroimaging to develop personalized rTMS targets to precisely modulate targeted underlying neurocircuitry has been successfully applied to the treatment of major depressive disorder (MDD). Similar methodology has been demonstrated successfully for smoking cessation by the candidate's mentors, but this work was completed in a sample of civilian participants making a quit attempt who did not have psychiatric illness. To fill these knowledge gaps, the proposed research aims to develop feasibility data for the therapeutic application individualized neuronavigated rTMS for Veterans with PTSD attempting to quit smoking. Using a feasibility randomized controlled trial (RCT) design, eligible Veterans with PTSD (n=50) seeking smoking cessation will receive rs-fMRI before and after a 5-day course of neuronavigated rTMS the week prior to their quit date, in conjunction with nicotine replacement therapy (NRT) and cognitive behavioral therapy (CBT). The scientific aims of the study are to evaluate feasibility of treatment delivery procedures, develop preliminary effect size estimates, and demonstrate target engagement of the intervention within neural networks critical to TUD.
- Conditions
- Tobacco Use Disorder
- Being tested
- active repetitive transcranial magnetic stimulation, sham repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation, nicotine replacement therapy
- Keywords
- Tobacco use cessation, Veterans
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active repetitive transcranial magnetic stimulationDevice
Also called active rTMS
Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.
sham repetitive transcranial magnetic stimulationDevice
Also called sham rTMS
Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
cognitive behavioral therapy for smoking cessationBehavioural
Also called CBT
All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
nicotine replacement therapyDrug
Also called NRT, nicotine patch, nicotine gum, nicotine lozenges
All participants will receive nicotine replacement therapy in for the form of 21 mg, 14 mg, and/or 7 mg nicotine patches (based on smoking quantity) and a "rescue" method such as nicotine lozenge or nicotine gum.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | Participants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment. Receives: Device: active repetitive transcranial magnetic stimulation; Behavioral: cognitive behavioral therapy for smoking cessation; Drug: nicotine replacement therapy |
| sham rTMS | Sham comparator | Participants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment. Receives: Device: sham repetitive transcranial magnetic stimulation; Behavioral: cognitive behavioral therapy for smoking cessation; Drug: nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by number of participants recruited
Number of participants recruited will serve as a measure of study feasibility. Target enrollment is 50 participants.
Measured: At consent
Feasibility as measured by the percent of participants who complete the study
The percent of participants who complete the 3-month follow-up visit will serve as a measure of treatment feasibility. 80% retention will be the cut point.
Measured: 3-month follow-up
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the end of treatment, and self-report is bioverified by exhaled carbon monoxide.
Measured: End of treatment, about five weeks after beginning study
Number of participants with self-reported and bioverified abstinence from smoking
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the 3-month follow-up visit, and self-report is bioverified by salivary cotinine.
Measured: 3-month follow-up
Secondary outcomes (14)
Average number of cigarettes smoked per day in past week
Participants will self-report the number of cigarettes they have smoked per day in the past week.
Measured: End of treatment, about five weeks after beginning study
Average number of cigarettes smoked per day in past week
Participants will self-report the number of cigarettes they have smoked per day in the past week.
Measured: 3-month follow-up
Self-reported withdrawal symptoms
Participants will self-report withdrawal symptoms on the Minnesota Nicotine Withdrawal Scale. Scores on this scale range from 0 to 36, with higher scores indicating higher severity of withdrawal symptoms.
Measured: End of treatment, about five weeks after beginning study
Self-reported withdrawal symptoms
Participants will self-report withdrawal symptoms on the Minnesota Nicotine Withdrawal Scale. Scores on this scale range from 0 to 36, with higher scores indicating higher severity of withdrawal symptoms.
Measured: 3-month follow-up
Self-report of craving based on Questionnaire of Smoking Urges
Participants will self-report cravings for tobacco on the Questionnaire of Smoking Urges. Scores on this scale range from 0 to 60, with higher scores indicating higher smoking craving.
Measured: End of treatment, about five weeks after beginning study
Self-report of craving based on Questionnaire of Smoking Urges
Participants will self-report cravings for tobacco on the Questionnaire of Smoking Urges. Scores on this scale range from 0 to 60, with higher scores indicating higher smoking craving.
Measured: 3-month follow-up
Number of participants who report relapse to smoking
Measured by self-report, smoking relapse is defined as smoking 5 or more cigarettes per day for 3 consecutive days.
Measured: End of treatment, about five weeks after beginning study
Number of participants who report relapse to smoking
Measured by self-report, smoking relapse is defined as smoking 5 or more cigarettes per day for 3 consecutive days.
Measured: 3-month follow-up
Functional network connectivity changes
Comparison of functional network connectivity (FNC) changes between the postcentral gyrus cortical rTMS target and right posterior insula using magnetic resonance imaging before and after the rTMS course
Measured: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Neuroimaging correlates to tobacco use
Correlation of resting state functional connectivity changes pre- vs post-rTMS course and the change in the number of cigarettes smoked in the past 24 hours
Measured: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will report smoking craving using this single-item measure. Scores range from 0 to 100 with higher scores indicating higher smoking craving.
Measured: End of treatment visit, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will report smoking craving using this single-item measure. Scores range from 0 to 100 with higher scores indicating higher smoking craving.
Measured: 3-month follow-up
Self-report of craving based on Urge to Smoke Scale
Participants will self-report craving on the single-item Urge to Smoke Scale. Scores on this scale range from 0 to 100, with higher scores indicating higher cravings to smoke.
Measured: End of treatment, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Participants will self-report craving on the single-item Urge to Smoke Scale. Scores on this scale range from 0 to 100, with higher scores indicating higher cravings to smoke.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start31 Oct 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan R Young, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723588
- Sponsor's protocol ID
- NURA-001-22S
- Other IDs
- 1625460, CX002610
- Acronym
- TMS-STOP
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
- ClinicalTrials.gov ID
- NCT05723588
- Acronym / sponsor ID
- TMS-STOP / NURA-001-22S
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco use cessation, Veterans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 10 Feb 2023 (actual)
- 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.
Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. This project seeks to evaluate the feasibility and effectiveness of a smoking cessation treatment for Veterans with posttraumatic stress disorder (PTSD) who smoke. The treatment combines smoking cessation counseling, nicotine replacement therapy (e.g., nicotine gum), and repetitive transcranial magnetic stimulation (rTMS). rTMS is a noninvasive brain stimulation treatment that has been cleared by the Food and Drug Administration for smoking cessation in adults.
Detailed description
Tobacco use remains the number one preventable cause of death in the United States. Unfortunately, individuals with mental health conditions are disproportionately affected. Tobacco use is also high among US Veterans, and those who have experienced trauma are even more likely to smoke. Successful quitting is especially difficult for individuals who develop posttraumatic stress disorder (PTSD). Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Neuroimaging techniques such as resting-state functional magnetic resonance imaging (rs-fMRI) have provided insight into the neurocircuitry of tobacco use disorder (TUD) and successful quit attempts. Interventions that modulate the neural systems underlying TUD, such as repetitive transcranial magnetic stimulation (rTMS), may be critical to improving clinical outcomes. Indeed, the US Food and Drug Administration (FDA) recently cleared a form of rTMS as a short-term smoking cessation treatment in adults. However, most clinical trials on rTMS for smoking cessation have been conducted in civilian samples and have excluded individuals with psychiatric conditions. To improve smoking cessation treatment options for Veterans with PTSD, it is critical to evaluate novel brain stimulation methods such as rTMS in this vulnerable population. Furthermore, the development of neuroscience-informed techniques to enhance rTMS such as neuronavigation based on rs-fMRI is critical to individualizing rTMS for smoking cessation and understanding mechanisms of action. The application of neuroimaging to develop personalized rTMS targets to precisely modulate targeted underlying neurocircuitry has been successfully applied to the treatment of major depressive disorder (MDD). Similar methodology has been demonstrated successfully for smoking cessation by the candidate's mentors, but this work was completed in a sample of civilian participants making a quit attempt who did not have psychiatric illness. To fill these knowledge gaps, the proposed research aims to develop feasibility data for the therapeutic application individualized neuronavigated rTMS for Veterans with PTSD attempting to quit smoking. Using a feasibility randomized controlled trial (RCT) design, eligible Veterans with PTSD (n=50) seeking smoking cessation will receive rs-fMRI before and after a 5-day course of neuronavigated rTMS the week prior to their quit date, in conjunction with nicotine replacement therapy (NRT) and cognitive behavioral therapy (CBT). The scientific aims of the study are to evaluate feasibility of treatment delivery procedures, develop preliminary effect size estimates, and demonstrate target engagement of the intervention within neural networks critical to TUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: active repetitive transcranial magnetic stimulation, Behavioral: cognitive behavioral therapy for smoking cessation, Drug: nicotine replacement therapyParticipants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment. |
| sham rTMS | Sham comparator | Device: sham repetitive transcranial magnetic stimulation, Behavioral: cognitive behavioral therapy for smoking cessation, Drug: nicotine replacement therapyParticipants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is a US Veteran
- Meets DSM-5 criteria for tobacco use disorder
- Is between the ages of 18 and 75
- Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppm
- Is willing to attempt smoking cessation
Key exclusion criteria (16 listed)
- Has had a substance use disorder other than tobacco in the preceding 3 months
- Has a history of myocardial infarction in the past 6 months or has another contraindication to NRT
- Has a contraindication to TMS or MRI
- Is unable to complete study procedures
- Is currently prescribed bupropion and/or varenicline
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 |
|---|---|---|
| active repetitive transcranial magnetic stimulationAlso: active rTMSActive rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults. | Device | active rTMS |
| sham repetitive transcranial magnetic stimulationAlso: sham rTMSSham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS. | Device | sham rTMS |
| cognitive behavioral therapy for smoking cessationAlso: CBTAll participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation. | Behavioural | active rTMS, sham rTMS |
| nicotine replacement therapyAlso: NRT, nicotine patch, nicotine gum, nicotine lozengesAll participants will receive nicotine replacement therapy in for the form of 21 mg, 14 mg, and/or 7 mg nicotine patches (based on smoking quantity) and a "rescue" method such as nicotine lozenge or nicotine gum. | Drug | active rTMS, sham rTMS |
Primary outcome
Feasibility as measured by number of participants recruited
Time frame: At consent
Number of participants recruited will serve as a measure of study feasibility. Target enrollment is 50 participants.
Feasibility as measured by the percent of participants who complete the study
Time frame: 3-month follow-up
The percent of participants who complete the 3-month follow-up visit will serve as a measure of treatment feasibility. 80% retention will be the cut point.
Number of participants with self-reported and bioverified abstinence from smoking
Time frame: End of treatment, about five weeks after beginning study
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the end of treatment, and self-report is bioverified by exhaled carbon monoxide.
Number of participants with self-reported and bioverified abstinence from smoking
Time frame: 3-month follow-up
Effectiveness of the intervention will be measured by the number of participants who self-report 7-day point prevalence at the 3-month follow-up visit, and self-report is bioverified by salivary cotinine.
14 secondary outcomes
Average number of cigarettes smoked per day in past week
Time frame: End of treatment, about five weeks after beginning study
Average number of cigarettes smoked per day in past week
Time frame: 3-month follow-up
Self-reported withdrawal symptoms
Time frame: End of treatment, about five weeks after beginning study
Self-reported withdrawal symptoms
Time frame: 3-month follow-up
Self-report of craving based on Questionnaire of Smoking Urges
Time frame: End of treatment, about five weeks after beginning study
Self-report of craving based on Questionnaire of Smoking Urges
Time frame: 3-month follow-up
Number of participants who report relapse to smoking
Time frame: End of treatment, about five weeks after beginning study
Number of participants who report relapse to smoking
Time frame: 3-month follow-up
Functional network connectivity changes
Time frame: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Neuroimaging correlates to tobacco use
Time frame: End of repetitive transcranial magnetic stimulation treatment, about three weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Time frame: End of treatment visit, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Time frame: 3-month follow-up
Self-report of craving based on Urge to Smoke Scale
Time frame: End of treatment, about five weeks after beginning study
Self-report of craving based on Urge to Smoke Scale
Time frame: 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan R Young, MD 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 Phase 2 study testing active repetitive transcranial magnetic stimulation, cognitive behavioral therapy for smoking cessation and nicotine replacement therapy in people with Tobacco Use Disorder, 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan R Young, MD ((919) 286-0411, jonathan.young14@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of participants recruited (time frame: At consent). The study lists 4 primary outcomes in all. 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 18 Feb 2026.