Marijuana ImpairmentEarly Phase 1NCT03191084
Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
A Early Phase 1 study testing Low Dose THC Marijuana and High Dose THC Marijuana in people with Marijuana Impairment, run by Yale University at 1 site in United States.
Trial summary
Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Impairment
- What is being tested?
- Low Dose THC Marijuana and High Dose THC Marijuana
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 30 Mar 2020
- Phase
- Early Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a current driver's license
- Have used marijuana before
- Right handed
Who cannot join
- Females who are pregnant or breast feeding
- Any serious medical, or neurological disorder
- Any psychiatric disorder
- No major head traumas
Trial locations and contacts
1 site in 1 country.
United States1 site
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106
About this study
Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)
Read the detailed description
This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Participants
- Conditions
- Marijuana Impairment
- Being tested
- Low Dose THC Marijuana, High Dose THC Marijuana, Placebo Marijuana
- Keywords
- marijuana, THC, cannabis, driving, impairment, intoxication
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose THC MarijuanaDrug
Also called THC, Cannabis
Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.
High Dose THC MarijuanaDrug
Also called THC, Cannabis
Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.
Placebo MarijuanaDrug
Also called THC, Cannabis
Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
| Study group | Role | What they receive |
|---|---|---|
| Regular Users | Experimental | People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits. Receives: Drug: Low Dose THC Marijuana; Drug: High Dose THC Marijuana; Drug: Placebo Marijuana |
| Occasional Users | Experimental | People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits. Receives: Drug: Low Dose THC Marijuana; Drug: High Dose THC Marijuana; Drug: Placebo Marijuana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana induced performance changes on Cogstate 1-back/2-back task.
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on Cogstate Card Learning.
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on Cogstate Groton Maze Learning task.
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on Cogstate Social/Emotional Cognition task.
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on Alertmeter.
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Time Estimation Task.
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Stop Signal Reaction Time task.
The Stop Signal Reaction Time Task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Critical Tracking Task.
The Critical Tracking Task assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the ANAM Pursuit Tracking Task.
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Finger to Nose Task.
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the One Leg Stand Task.
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Line Walking/Months Backwards Task.
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Marijuana induced performance changes on the Time Reproduction Task.
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Measured: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
Secondary outcomes (6)
Change in concentration of THC/metabolites in blood samples.
Blood samples with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.
Oral fluid samples with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Oral fluid samples with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in performance on simulated driving Road Tracking Task.
The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane.
Measured: Post drug administration at: 1 hour, 3 hours and 5 hours
Change in performance on simulated driving Car Following Task.
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Measured: Post drug administration at: 1 hour, 3 hours and 5 hours
Change in performance on simulated driving Gap Acceptance Task.
The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into oncoming traffic to overtake a stopped car.
Measured: Post drug administration at: 1 hour, 3 hours and 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Dec 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana ImpairmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Hartford Hospital, Montana State University, Maastricht University, The Mind Research Network, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Godfrey Pearlson, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191084
- Sponsor's protocol ID
- 2000021338
- Other IDs
- DTNH2216C00022
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
- ClinicalTrials.gov ID
- NCT03191084
- Acronym / sponsor ID
- 2000021338
- Conditions
- Marijuana Impairment
- Keywords
- marijuana, THC, cannabis, driving, impairment, intoxication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), Hartford Hospital, Montana State University, Maastricht University, The Mind Research Network, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 19 Jun 2017 (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.
Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)
Detailed description
This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Participants
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Users | Experimental | Drug: Low Dose THC Marijuana, Drug: High Dose THC Marijuana, Drug: Placebo MarijuanaPeople who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits. |
| Occasional Users | Experimental | Drug: Low Dose THC Marijuana, Drug: High Dose THC Marijuana, Drug: Placebo MarijuanaPeople who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have a current driver's license
- Have used marijuana before
- Right handed
Key exclusion criteria (4 listed)
- Females who are pregnant or breast feeding
- Any serious medical, or neurological disorder
- Any psychiatric disorder
- No major head traumas
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 |
|---|---|---|
| Low Dose THC MarijuanaAlso: THC, CannabisDosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits. | Drug | Occasional Users, Regular Users |
| High Dose THC MarijuanaAlso: THC, CannabisDosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits. | Drug | Occasional Users, Regular Users |
| Placebo MarijuanaAlso: THC, CannabisDosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits. | Drug | Occasional Users, Regular Users |
Primary outcome
Marijuana induced performance changes on Cogstate 1-back/2-back task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Card Learning.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Groton Maze Learning task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Social/Emotional Cognition task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Alertmeter.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Time Estimation Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Stop Signal Reaction Time task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Stop Signal Reaction Time Task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Critical Tracking Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Critical Tracking Task assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the ANAM Pursuit Tracking Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Finger to Nose Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the One Leg Stand Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Line Walking/Months Backwards Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Time Reproduction Task.
Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
6 secondary outcomes
Change in concentration of THC/metabolites in blood samples.
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Change in performance on simulated driving Road Tracking Task.
Time frame: Post drug administration at: 1 hour, 3 hours and 5 hours
Change in performance on simulated driving Car Following Task.
Time frame: Post drug administration at: 1 hour, 3 hours and 5 hours
Change in performance on simulated driving Gap Acceptance Task.
Time frame: Post drug administration at: 1 hour, 3 hours and 5 hours
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 23 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Dose THC Marijuana and High Dose THC Marijuana in people with Marijuana Impairment, run by Yale 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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Marijuana induced performance changes on Cogstate 1-back/2-back task. (time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours). The study lists 13 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 23 Jul 2024.