Cocaine Use DisorderPhase 2NCT04843046

Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention

A Phase 2 study testing Cognitive Behavioral Therapy (CBT) and Pioglitazone in people with Cocaine Use Disorder, run by The University of Texas Health Science Center, Houston 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

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cocaine Use Disorder
What is being tested?: Cognitive Behavioral Therapy (CBT) and Pioglitazone
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 23 Aug 2021to 15 Oct 2025
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 to 65 years old
meet DSM 5 diagnostic criteria for cocaine use disorder
report recent cocaine use, verified by at least one positive urine drug screen for the cocaine metabolite, benzoylecgonine, during intake
be judged by the medical staff to be psychiatrically stable and physically healthy
for females, be using an effective form of birth control (e.g., barrier, IUD, or sterilization) and not be pregnant as determined by a serum pregnancy test at screening and negative urine pregnancy test at intake prior to first dose of investigational drug (test will be repeated weekly to ensure that female patients do not continue in the study if pregnant) or lactating
be willing to be admitted to a 5-day inpatient detoxification program at The Right Step Houston
be able to understand the consent form and provide written informed consent
be able to provide the names of at least 2 persons who can consistently locate their whereabouts

Who cannot join

have an acute medical or psychiatric disorder that would, in the judgment of the study physician, make participation difficult or unsafe
have suicidal or homicidal ideation that requires immediate attention
have another current (≥ moderate) substance use disorder aside from alcohol, nicotine, or marijuana
have a medical condition contraindicating PIO pharmacotherapy (e.g., drug- or insulin-dependent diabetes, congestive heart failure, edema, clinical significant liver disease, hypoglycemia, history of bladder cancer) or be taking medications that would adversely interact with PIO (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
be concurrently enrolled in other addiction treatment services aside from smoking cessation
if female, be currently pregnant, breastfeeding, or planning on conception

Show all 10Show fewer

have conditions of probation or parole requiring reports of drug use to officers of the court
be unable to read, write, or speak English
be homeless (live on the street)
have medical contraindications to MRI/DTI scans (e.g., history of pacemaker, metal implants, or welding/metal work without protective eyewear)

Trial locations and contacts

1 site in 1 country.

United States1 site

UTHealth Center for Neurobehavioral Research on Addiction
Houston, Texas, 77054

Other trials in United States

About this study

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.

Read the detailed description

Over one million American adults suffer from cocaine use disorder (CUD) with recent trends showing an increase in cocaine-related deaths since 2010. For the chronic cocaine user, significant changes in brain function and structure set the stage for relapse that, unfortunately, continues to be the most common outcome following treatment. For substance use disorders, cognitive-behavioral therapy (CBT) is arguably the most empirically supported and widely used relapse prevention approach. Considered to be a cognitive control therapy, CBT aims to improve 'top-down' executive control functions that are impaired in CUD and strongly connected to relapse. Converging evidence suggests that CBT promotes meaningful changes in brain regions associated with cognitive control. Still, many patients with cognitive impairments show suboptimal response to CBT, bolstering the call for research aimed at improving effects with integrative treatments.

The goal of this project is to enhance the relapse-prevention effects of CBT with adjunctive use of pioglitazone (PIO), a peroxisome proliferator-activated receptor gamma (PPAR-γ) agonist. Unlike traditional medications that target classic neurotransmitter systems, PIO's activation of the PPAR pathway confers broad spectrum anti-inflammatory and neuroprotective effects against insult to brain white matter (WM). The functional significance of WM in CUD has been well established by evidence showing that: (1) chronic cocaine exposure alters WM structural integrity; (2) WM alterations compromise cognitive function in CUD; and (2) better WM integrity predicts better CUD treatment outcome. In a recent proof of concept trial it was found that PIO significantly improved brain WM integrity in a small sample of non-abstinent patients with CUD. Treatment with PIO was well-tolerated and associated with reduced cocaine craving relative to placebo. Collectively, these findings raise the exciting possibility that PIO may augment responding to CBT via improved neural structure and cognitive function.

A randomized double-blind clinical trial will be utilized to evaluate the efficacy of CBT with adjunctive PIO in recently abstinent patients during the early phase of recovery when craving is prominent, relapse risk is high, and intact cognitive control is required to actively maintain abstinence. Upon completion of a 5-day inpatient detoxification, 60 adults with CUD will complete titration to full dose of randomized medication, either PIO (45mg daily) or placebo, and begin 12 weeks of outpatient CBT treatment while continuing to receive study medication. Specific aims will examine the effects of PIO on targeted mechanisms of change (WM integrity, cognitive function, cocaine craving) and demonstrate evidence linking clinical efficacy (abstinence, functional health) with mechanism engagement. Expected results will establish PIO as an adjunctive treatment that can be integrated with CBT to reduce relapse risk following detoxification, thereby meeting NIDA's strategic priority of evaluating the use of medications to improve the efficacy of behavioral interventions (PA-18-055).

Conditions: Cocaine Use Disorder
Being tested: Cognitive Behavioral Therapy (CBT), Pioglitazone, Placebo
Keywords: Cocaine Use, Cocaine Addiction, Cognitive Behavioral Therapy, Relapse Prevention
Medical subject headings: Cocaine-Related Disorders

What participants receive

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

Cognitive Behavioral Therapy (CBT)Behavioural
Also called CBT
All participants will receive evidence-based individual Cognitive Behavioral Therapy (CBT) shown to be an effective intervention for maintaining abstinence following detoxification. Trained masters-level licensed professional counselors will deliver CBT.
PioglitazoneDrug
Also called Actos
Pioglitazone capsules will start at 30 mg (Detox days 3 and 4) and increase to fixed dose of 45 mg for study weeks 1-12 and will also contain riboflavin.
PlaceboDrug
Also called Corn Starch
Placebo capsules will be filled with corn starch and riboflavin.

Study groups in NCT04843046
Study group	Role	What they receive
CBT + pioglitazone	Active comparator	Cognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a pioglitazone (45 mg) capsule every day during weeks 1-12. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Pioglitazone
CBT + placebo	Placebo comparator	Cognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a placebo capsule every day during weeks 1-12. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Placebo

What is being measured

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

Change in white matter integrity as assessed by change in fractional anisotropy value measured by diffusion tensor imaging
Anisotropy values range from 0 to 1, where a higher value indicates greater white matter integrity.
Measured: Week 0 and Week 12
Change in white matter integrity as assessed by change in radial diffusivity value measured by diffusion tensor imaging
Radial diffusivity (RD) values are not bound by specified upper and lower ranges, as the metric is a derivation of two diffusion eigenvalues = ([lambda2 / lambda3] / 2). Higher RD values are indicative of decreased white matter integrity as related to myelin integrity; conversely lower RD scores indicate better white matter integrity.
Measured: Week 0 and Week 12
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 0
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 4
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 12
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 0
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 4
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Measured: Week 12
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Measured: Week 0
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Measured: Week 4
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Measured: Week 12
Number of participants who don't relapse as assessed by continuous cocaine-negative urine drug screens in the final three weeks of treatment
For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 150 ng/mL.
Measured: From Week 10 to Week 12
Self-reported craving for cocaine as assessed by average Brief Substance Craving Scale score across 12 weeks of treatment
The Brief Substance Craving Scale (BSCS) score ranges from 0 to 4, with a higher score indicating greater craving. Participants will be assessed by BSCS once per week for 12 weeks, and the average BSCS score over the 12 weeks will be reported.
Measured: From Week 1 to Week 12
Self-reported craving for cocaine as assessed by average Visual Analogue Scale score across 12 weeks of treatment
The Visual Analogue Scale (VAS) score ranges from 0 to 100, with a higher score indicating greater craving. Participants will be assessed by VAS once per week for 12 weeks, and the average VAS score over the 12 weeks will be reported.
Measured: From Week 1 to Week 12

Secondary outcomes (5)

Total percentage of days abstinent during treatment as assessed by self-reported non-use days confirmed by cocaine-negative urine drug screen results
For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 150 ng/mL.
Measured: From Week 1 to Week 12
Total percentage of cocaine-negative urine drug screens during treatment as assessed by number of cocaine-negative samples out of total number of urine samples provided
For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 150 ng/mL.
Measured: From Week 1 to Week 12
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
The PROMIS global health summary score is a T-score derived from the global physical health (GPH) and global mental health (GMH) items and ranges from 40 to 60, with a greater T-score indicating better functional health status.
Measured: Week 0
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
The PROMIS global health summary score is a T-score derived from the global physical health (GPH) and global mental health (GMH) items and ranges from 40 to 60, with a greater T-score indicating better functional health status.
Measured: Week 4
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
The PROMIS global health summary score is a T-score derived from the global physical health (GPH) and global mental health (GMH) items and ranges from 40 to 60, with a greater T-score indicating better functional health status.
Measured: Week 12

Timeline

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

23 Aug 202115 Oct 2025

First posted13 Apr 2021
Study start23 Aug 2021
Primary completion26 Sep 2025
Study completion15 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04843046
Sponsor's protocol ID: HSC-MS-19-0718
Other IDs: R01DA048026
Status last verified: Sep 2026
First submitted: 8 Apr 2021
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 Cocaine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pioglitazone as an Adjunct to Cognitive-Behavioral Therapy for Cocaine Relapse Prevention
ClinicalTrials.gov ID: NCT04843046
Acronym / sponsor ID: HSC-MS-19-0718
Conditions: Cocaine Use Disorder
Keywords: Cocaine Use, Cocaine Addiction, Cognitive Behavioral Therapy, Relapse Prevention
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 23 Aug 2021 (actual)
Primary completion: 26 Sep 2025 (actual)
Study completion: 15 Oct 2025 (actual)
First posted: 13 Apr 2021 (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.

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CBT + pioglitazone	Active comparator	Behavioral: Cognitive Behavioral Therapy (CBT), Drug: PioglitazoneCognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a pioglitazone (45 mg) capsule every day during weeks 1-12.
CBT + placebo	Placebo comparator	Behavioral: Cognitive Behavioral Therapy (CBT), Drug: PlaceboCognitive Behavioral Therapy will be administered twice weekly during weeks 1-4 and once weekly during weeks 5-12 and augmented with a placebo capsule every day during weeks 1-12.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

18 to 65 years old
meet DSM 5 diagnostic criteria for cocaine use disorder
report recent cocaine use, verified by at least one positive urine drug screen for the cocaine metabolite, benzoylecgonine, during intake
be judged by the medical staff to be psychiatrically stable and physically healthy
for females, be using an effective form of birth control (e.g., barrier, IUD, or sterilization) and not be pregnant as determined by a serum pregnancy test at screening and negative urine pregnancy test at intake prior to first dose of investigational drug (test will be repeated weekly to ensure that female patients do not continue in the study if pregnant) or lactating

Key exclusion criteria (10 listed)

have an acute medical or psychiatric disorder that would, in the judgment of the study physician, make participation difficult or unsafe
have suicidal or homicidal ideation that requires immediate attention
have another current (≥ moderate) substance use disorder aside from alcohol, nicotine, or marijuana
have a medical condition contraindicating PIO pharmacotherapy (e.g., drug- or insulin-dependent diabetes, congestive heart failure, edema, clinical significant liver disease, hypoglycemia, history of bladder cancer) or be taking medications that would adversely interact with PIO (e.g., CYP2C8 inhibitors or inducers, antihyperglycemic medications)
be concurrently enrolled in other addiction treatment services aside from smoking cessation

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
Cognitive Behavioral Therapy (CBT)Also: CBTAll participants will receive evidence-based individual Cognitive Behavioral Therapy (CBT) shown to be an effective intervention for maintaining abstinence following detoxification. Trained masters-level licensed professional counselors will deliver CBT.	Behavioural	CBT + pioglitazone, CBT + placebo
PioglitazoneAlso: ActosPioglitazone capsules will start at 30 mg (Detox days 3 and 4) and increase to fixed dose of 45 mg for study weeks 1-12 and will also contain riboflavin.	Drug	CBT + pioglitazone
PlaceboAlso: Corn StarchPlacebo capsules will be filled with corn starch and riboflavin.	Drug	CBT + placebo

Primary outcome

Change in white matter integrity as assessed by change in fractional anisotropy value measured by diffusion tensor imaging
Time frame: Week 0 and Week 12
Anisotropy values range from 0 to 1, where a higher value indicates greater white matter integrity.
Change in white matter integrity as assessed by change in radial diffusivity value measured by diffusion tensor imaging
Time frame: Week 0 and Week 12
Radial diffusivity (RD) values are not bound by specified upper and lower ranges, as the metric is a derivation of two diffusion eigenvalues = ([lambda2 / lambda3] / 2). Higher RD values are indicative of decreased white matter integrity as related to myelin integrity; conversely lower RD scores indicate better white matter integrity.
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
Time frame: Week 0
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
Time frame: Week 4
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in working memory as assessed by the NIH Toolbox Cognition Battery List Sorting Task
Time frame: Week 12
The List Sorting Task has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
Time frame: Week 0
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
Time frame: Week 4
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in attention/impulsivity as assessed by the NIH Toolbox Cognition Battery Flanker Test
Time frame: Week 12
The Flanker Test has an age-adjusted scale score that ranges from 0 to 100, with a higher score indicating better performance.
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
Time frame: Week 0
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
Time frame: Week 4
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Change in cognitive function as assessed by the NIH Toolbox Cognition Battery Fluid Cognition Composite score
Time frame: Week 12
The Fluid Cognition Composite score is the normed standardized score ranging from 0 to 145, with a higher score indicating better performance.
Number of participants who don't relapse as assessed by continuous cocaine-negative urine drug screens in the final three weeks of treatment
Time frame: From Week 10 to Week 12
For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 150 ng/mL.
Self-reported craving for cocaine as assessed by average Brief Substance Craving Scale score across 12 weeks of treatment
Time frame: From Week 1 to Week 12
The Brief Substance Craving Scale (BSCS) score ranges from 0 to 4, with a higher score indicating greater craving. Participants will be assessed by BSCS once per week for 12 weeks, and the average BSCS score over the 12 weeks will be reported.
Self-reported craving for cocaine as assessed by average Visual Analogue Scale score across 12 weeks of treatment
Time frame: From Week 1 to Week 12
The Visual Analogue Scale (VAS) score ranges from 0 to 100, with a higher score indicating greater craving. Participants will be assessed by VAS once per week for 12 weeks, and the average VAS score over the 12 weeks will be reported.

5 secondary outcomes

Total percentage of days abstinent during treatment as assessed by self-reported non-use days confirmed by cocaine-negative urine drug screen results
Time frame: From Week 1 to Week 12
Total percentage of cocaine-negative urine drug screens during treatment as assessed by number of cocaine-negative samples out of total number of urine samples provided
Time frame: From Week 1 to Week 12
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
Time frame: Week 0
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
Time frame: Week 4
Functional health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) global health summary score
Time frame: Week 12

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 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Cocaine Use Disorder

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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.

Joy M Schmitz, PhD principal investigator

UT Houston

Scott D Lane, PhD principal investigator

UT Houston

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 8 inclusion and 10 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 Sep 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?

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?

Change in white matter integrity as assessed by change in fractional anisotropy value measured by diffusion tensor imaging (time frame: Week 0 and Week 12). The study lists 14 primary outcomes in all. 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 NCT04843046.

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 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.