PostTraumatic Stress DisorderPhase 4NCT03008005
Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
A Phase 4 study testing Dronabinol Cap 5 milligrams (MG) and Dronabinol Cap 10 milligrams (MG) in people with PostTraumatic Stress Disorder, run by Wayne State University at 1 site in United States.
Trial summary
The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- PostTraumatic Stress Disorder
- What is being tested?
- Dronabinol Cap 5 milligrams (MG) and Dronabinol Cap 10 milligrams (MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Dec 2019
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to give informed consent
- Right-handed
- Age between 18-50 years old,
- Physically and neurologically healthy [confirmed by a comprehensive medical history]
- Current PTSD diagnosis
Who cannot join
- clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol
- any current (or within past 2 months) medical condition requiring medication that would interact with dronabinol or interfere with the study protocol
- risk of harm to self or others that requires immediate intervention
- presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
- lack of fluency in English
- positive drug screen or alcohol breathalyzer
Show all 18Show fewer
- unwilling/unable to sign informed consent document
- currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women)
- under 18 or over 50 years of age
- traumatic brain injury (as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement (i.e., whiplash) without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)
- inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner
- left-handed;
- presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- anticipation of a required drug test in the 4 weeks following the study.
- current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD
- current moderate or severe alcohol/drug use disorder or in the past 8 weeks
- current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders
- concomitant treatments with medication known to have drug interactions with dronabinol, such as, central nervous system depressants (barbiturates, benzodiazepines, buspirone, lithium, etc) and anticholinergic agents (atropine, scopolamine, antihistamines, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
Eugene Applebaum College of Pharmacy and Health Sciences
Detroit, Michigan, 48201
About this study
Official title: Effects of THC on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.
Read the detailed description
The total time that for each participant involved in this study is 5 visits, as outlined below:
Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will learn about the study procedures, sign the informed consent documents, and fill out a packet of forms that ask about his or her race and ethnic background, use of drugs and alcohol and physical and mental health.
Visit 2: Behavioral Tests: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures.The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. loud burst of noise or animated snake) may follow one image most of the time, while the other images may never be followed by the aversive cue. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks an aversive cue will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100.
Visit 3: Behavioral Tests with Drug or Placebo and Magnetic Resonance (MR) scan: For safety reasons participant will not be allowed to take any drugs for at least 24 hours before this visit, and should not use marijuana for at least 2 weeks before. Participants will be required to pass a urine drug test (and pregnancy test for women) and breathalyzer test before being allowed to continue with this visit. The participant will also not be allowed to drive himself or herself home from this visit, so he or she should arrange a friend or family member to pick him or her up or a taxi can be called by our research staff.
The participant will view the same images he or she did on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. The participant will again be asked to rate how much he or she expects to experience the aversive stimulus after each image and he or she will also be asked to report his or her level of anxiety on a scale from 0 to 100. However, about 2 hours before the task begins, the participant will be asked to swallow a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill). Dronabinol is a Food \& Drug Administration (FDA) approved drug and the doses (5mg or 10mg; one time) are unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires about mood and how he or she is feeling at the moment.
Visit 4: Behavioral Tests and MR scan: This visit will be very similar to Visit 2. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously, and may experience the same aversive stimulus as during Visit 2. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100.
Visit 5: Behavioral Tests and MR scan: This visit will occur approximately 1 week after Visit 4 and will have the same procedure. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100.
- Conditions
- PostTraumatic Stress Disorder
- Being tested
- Placebo Oral Capsule, Dronabinol Cap 5 milligrams (MG), Dronabinol Cap 10 milligrams (MG)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral CapsuleDrug
Also called sugar pill
Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.
Dronabinol Cap 5 milligrams (MG)Drug
Also called Marinol
Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
Dronabinol Cap 10 milligrams (MG)Drug
Also called Marinol
Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Oral Capsule | Placebo comparator | In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). Receives: Drug: Placebo Oral Capsule |
| Dronabinol Cap 5 milligrams (MG) | Experimental | In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). Receives: Drug: Dronabinol Cap 5 milligrams (MG) |
| Dronabinol Cap 10 milligrams (MG) | Experimental | In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). Receives: Drug: Dronabinol Cap 10 milligrams (MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Measures
Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.
Measured: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day
Expectancy Ratings
To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of "yes", "no", and "I don't know" are collected on the first (early) trial of the CS and the last (late) trial of the CS.
Measured: Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Rabinak, PhD, Wayne State University
- Investigators
- Christine A. Rabinak, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008005
- Sponsor's protocol ID
- 1R61MH111935-01
- Status last verified
- Aug 2025
- First submitted
- 23 Dec 2016
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of THC on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
- ClinicalTrials.gov ID
- NCT03008005
- Acronym / sponsor ID
- 1R61MH111935-01
- Conditions
- PostTraumatic Stress Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 8 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.
Detailed description
The total time that for each participant involved in this study is 5 visits, as outlined below:
Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will learn about the study procedures, sign the informed consent documents, and fill out a packet of forms that ask about his or her race and ethnic background, use of drugs and alcohol and physical and mental health.
Visit 2: Behavioral Tests: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures.The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. loud burst of noise or animated snake) may follow one image most of the time, while the other images may never be followed by the aversive cue. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks an aversive cue will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100.
Visit 3: Behavioral Tests with Drug or Placebo and Magnetic Resonance (MR) scan: For safety reasons participant will not be allowed to take any drugs for at least 24 hours before this visit, and should not use marijuana for at least 2 weeks before. Participants will be required to pass a urine drug test (and pregnancy test for women) and breathalyzer test before being allowed to continue with this visit. The participant will also not be allowed to drive himself or herself home from this visit, so he or she should arrange a friend or family member to pick him or her up or a taxi can be called by our research staff.
The participant will view the same images he or she did on the previous day (Visit 2), and may experience the same aversive stimulus as during Visit 2. The participant will again be asked to rate how much he or she expects to experience the aversive stimulus after each image and he or she will also be asked to report his or her level of anxiety on a scale from 0 to 100. However, about 2 hours before the task begins, the participant will be asked to swallow a capsule containing either a marijuana-like drug (Dronabinol) or a placebo (sugar pill). Dronabinol is a Food \& Drug Administration (FDA) approved drug and the doses (5mg or 10mg; one time) are unlikely to have any effects that last beyond the duration of the study visit. About every 30 minutes after taking the pill, the participant will fill out some questionnaires about mood and how he or she is feeling at the moment.
Visit 4: Behavioral Tests and MR scan: This visit will be very similar to Visit 2. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously, and may experience the same aversive stimulus as during Visit 2. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100.
Visit 5: Behavioral Tests and MR scan: This visit will occur approximately 1 week after Visit 4 and will have the same procedure. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral CapsuleIn a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). |
| Dronabinol Cap 5 milligrams (MG) | Experimental | Drug: Dronabinol Cap 5 milligrams (MG)In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). |
| Dronabinol Cap 10 milligrams (MG) | Experimental | Drug: Dronabinol Cap 10 milligrams (MG)In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to give informed consent
- Right-handed
- Age between 18-50 years old,
- Physically and neurologically healthy [confirmed by a comprehensive medical history]
- Current PTSD diagnosis
Key exclusion criteria (18 listed)
- clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol
- any current (or within past 2 months) medical condition requiring medication that would interact with dronabinol or interfere with the study protocol
- risk of harm to self or others that requires immediate intervention
- presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
- lack of fluency in English
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 |
|---|---|---|
| Placebo Oral CapsuleAlso: sugar pillPlacebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules. | Drug | Placebo Oral Capsule |
| Dronabinol Cap 5 milligrams (MG)Also: MarinolDronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler. | Drug | Dronabinol Cap 5 milligrams (MG) |
| Dronabinol Cap 10 milligrams (MG)Also: MarinolDronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler. | Drug | Dronabinol Cap 10 milligrams (MG) |
Primary outcome
Brain Measures
Time frame: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day
Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests [amygdala; ventromedial prefrontal cortex; hippocampus] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.
Expectancy Ratings
Time frame: Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.
To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)]. Counts of "yes", "no", and "I don't know" are collected on the first (early) trial of the CS and the last (late) trial of the CS.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Christine A. Rabinak, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol Cap 5 milligrams (MG) and Dronabinol Cap 10 milligrams (MG) in people with PostTraumatic Stress Disorder, run by Wayne State 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 18 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 22 Aug 2025. 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 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 8 Sep 2022). 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?
Brain Measures (time frame: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day). The study lists 2 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 22 Aug 2025.