Intoxication AlcoholfNIRSNCT03655717

Using Imaging to Assess Effects of THC on Brain Activity

A study testing Dronabinol and Ethanol in people with Intoxication Alcohol and Intoxication THC, run by Massachusetts General Hospital at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Intoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC
What is being tested?: Dronabinol and Ethanol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 316 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2018to 21 Jan 2021
Phase: Interventional
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)
Competent and willing to provide written informed consent;
Able to communicate in English language.
Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC
Additional Inclusion Criteria For Phase 2B:
Past consumption of at least two alcoholic beverages in one occasion.
Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects.
Weigh more than 100 lbs.

Who cannot join

General (Phase 2A, 2B 3)
Any unstable, serious medical illness, or cardiovascular disease or events.
New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,
Diabetes, cirrhosis, renal failure, Hepatitis C, HIV,
History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours);
Allergy to sesame oil (contained in Marinol pills) or Marinol capsules

Show all 11Show fewer

Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents;
Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)
In the opinion of the investigator, not able to safely participate in this study.
Additional Exclusion Criteria For Phase 2B:
Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
Boston, Massachusetts, 02114

Other trials in United States

About this study

This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.

Read the detailed description

This study will assess the effects of THC intoxication using dronabinol (synthetic THC) on the oxyhemoglobin (HbO) signal during resting state and task-based activation in the prefrontal cortex (PFC) and resting state connectivity, as well as on neurocognitive task performance and correlations between these measurements and clinical signs of intoxication. Participants will be 150 adults who use marijuana at least monthly (aged 18-55) will be recruited to participate in this study. Participants will be given up to 80 mg of dronabinol, an FDA-approved synthetic form of THC that is used to treat loss of appetite that causes weight loss in people with AIDS. THC is the principle psychoactive drug in marijuana. The study will be conducted in regular cannabis users who present at their first study visit with a positive urine screen for THC metabolites.

Phase 2A. Investigate the effect of THC on fNIRS brain signature and its association with self-reported intoxication, laboratory measures of impairment, and the gold-standard behavioral field test of driving impairment used by law enforcement, the primary classifier.

Phase 2B. Examine potential interaction following co-administration of THC with oral ethanol exposure in healthy volunteers. Phase II is a randomized, double-blind, placebo-controlled, 2 by 2 crossover study of effect of dronabinol, ethanol, and combined dronabinol and ethanol on brain activation and connectivity as measured by fNIRS.

Conditions: Intoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC
Being tested: Dronabinol, Ethanol, Placebo dronabinol, Placebo ethanol
Keywords: fNIRS, THC, Intoxication
Medical subject headings: Alcoholic Intoxication

What participants receive

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

DronabinolDrug
Also called oral THC
Dronabinol at physician determined doses of 10-80mg designed to produce intoxication.
EthanolDrug
Also called oral ethanol
Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
Placebo dronabinolDrug
Also called placebo oral THC
Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)
Placebo ethanolDrug
Also called oral placebo ethanol
Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.

Study groups in NCT03655717
Study group	Role	What they receive
Phase 2A	Experimental	In a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order. Receives: Drug: Dronabinol; Drug: Placebo dronabinol
Phase 2B	Experimental	In a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, \& dronabinol + ethanol. Receives: Drug: Dronabinol; Drug: Ethanol; Drug: Placebo dronabinol; Drug: Placebo ethanol

What is being measured

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

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.
Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity.
Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).
Measured: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.

Timeline

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

5 Nov 201821 Jan 2021

First posted31 Aug 2018
Study start5 Nov 2018
Primary completion21 Jan 2021
Study completion21 Jan 2021

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intoxication AlcoholStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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 N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: In Phase 2A, a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order. In Phase 2B, a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 24 sequences of each of the following treatments: placebo dronabinol and placebo ethanol, placebo dronabinol and ethanol, dronabinol and placebo ethanol, and dronabinol and ethanol.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03655717
Sponsor's protocol ID: 2015P001516
Other IDs: R42DA043977
Acronym: fNIRS
Status last verified: Jul 2022
First submitted: 20 Jul 2018
Last updated: 28 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be available

Publications

Berchansky M, Evins AE, Evohr B, Himmelsbach Z, Pachas GN, Karunakaran KD, Laufer Goldshtein B, Ozana N, Gilman JM. Detection of Delta9-Tetrahydrocannabinol Impairment Using Resting-State Functional Near-Infrared Spectroscopy: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2556647. doi: 10.1001/jamanetworkopen.2025.56647.
PubMed 41615687
Karunakaran KD, Pascale M, Ozana N, Potter K, Pachas GN, Evins AE, Gilman JM. Intoxication due to Delta9-tetrahydrocannabinol is characterized by disrupted prefrontal cortex activity. Neuropsychopharmacology. 2024 Aug;49(9):1481-1490. doi: 10.1038/s41386-024-01876-5. Epub 2024 May 7.
PubMed 38714786
Gilman JM, Schmitt WA, Potter K, Kendzior B, Pachas GN, Hickey S, Makary M, Huestis MA, Evins AE. Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging. Neuropsychopharmacology. 2022 Mar;47(4):944-952. doi: 10.1038/s41386-021-01259-0. Epub 2022 Jan 8.
PubMed 34999737

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?

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All Intoxication Alcohol trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Imaging to Assess Effects of THC on Brain Activity
ClinicalTrials.gov ID: NCT03655717
Acronym / sponsor ID: fNIRS / 2015P001516
Conditions: Intoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC
Keywords: fNIRS, THC, Intoxication
Study type: Interventional
Recruitment status: Completed
Enrolment: 316 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Nov 2018 (actual)
Primary completion: 21 Jan 2021 (actual)
Study completion: 21 Jan 2021 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 28 Jul 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: In Phase 2A, a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order. In Phase 2B, a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 24 sequences of each of the following treatments: placebo dronabinol and placebo ethanol, placebo dronabinol and ethanol, dronabinol and placebo ethanol, and dronabinol and ethanol.

Arm	Type	Receives
Phase 2A	Experimental	Drug: Dronabinol, Drug: Placebo dronabinolIn a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order.
Phase 2B	Experimental	Drug: Dronabinol, Drug: Ethanol, Drug: Placebo dronabinol, Drug: Placebo ethanolIn a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, \& dronabinol + ethanol.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)
Competent and willing to provide written informed consent;
Able to communicate in English language.
Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC
Past consumption of at least two alcoholic beverages in one occasion.

Key exclusion criteria (11 listed)

General (Phase 2A, 2B 3)
Any unstable, serious medical illness, or cardiovascular disease or events.
New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,
Diabetes, cirrhosis, renal failure, Hepatitis C, HIV,
History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours);

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
DronabinolAlso: oral THCDronabinol at physician determined doses of 10-80mg designed to produce intoxication.	Drug	Phase 2A, Phase 2B
EthanolAlso: oral ethanolOral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).	Drug	Phase 2B
Placebo dronabinolAlso: placebo oral THCIdentical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)	Drug	Phase 2A, Phase 2B
Placebo ethanolAlso: oral placebo ethanolPlacebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.	Drug	Phase 2B

Primary outcome

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.
Time frame: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.
Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).

Results and safety

Results posted to the registry on 28 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 2A: AB	70	60
Phase 2A: BA	68	56
Phase 2B: CDEF	2	1
Phase 2B: CDFE	1	0
Phase 2B: CEDF	0	0
Phase 2B: CEFD	3	1
Phase 2B: CFDE	3	0
Phase 2B: CFED	3	2
Phase 2B: DCEF	2	0
Phase 2B: DCFE	1	0
Phase 2B: DECF	1	1
Phase 2B: DEFC	3	1
Phase 2B: DFCE	2	2
Phase 2B: DFEC	3	0
Phase 2B: ECDF	2	2
Phase 2B: ECFD	2	1
Phase 2B: EDCF	2	2
Phase 2B: EDFC	2	2
Phase 2B: EFCD	3	2
Phase 2B: EFDC	3	2
Phase 2B: FCDE	2	2
Phase 2B: FCED	3	2
Phase 2B: FDCE	2	0
Phase 2B: FDEC	4	2
Phase 2B: FECD	1	0
Phase 2B: FEDC	2	2

Primary outcome: Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.

Time frame: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.. Mean (Standard Deviation). Unit: Δ mol/L

Measure	Phase 2A: Dronabinol Only n = 119	Phase 2A: Placebo Dronabinol Only n = 115	Phase 2B: Dronabinol and Ethanol n = 30	Phase 2B: Dronabinol and Placebo Ethanol n = 31	Phase 2B: Placebo Dronabinol and Ethanol n = 28	Phase 2B: Placebo Dronabinol and Placebo Ethanol n = 34
Predose	0.00000000042 (0.00000011109)	-0.00000000126 (0.00000012928)	-0.00000000271 (0.00000015932)	-0.00000000114 (0.00000015048)	-0.00000000151 (0.00000009318)	-0.00000000219 (0.00000012507)
Peak	0.00000000013 (0.00000010190)	0.00000000029 (0.00000012394)	-0.00000000041 (0.00000010552)	-0.00000000020 (0.00000012457)	-0.00000000018 (0.00000009089)	0.00000000070 (0.00000011546)

Phase 2A: Dronabinol Only vs Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Dronabinol and Placebo Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol: Mean Difference (Final Values): -0.038 (95% CI -0.259 to 0.184), p = 0.94, Regression, Linear
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol: Mean Difference (Final Values): -0.018 (95% CI -0.421 to 0.386), p = 0.94, Regression, Linear
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol: Mean Difference (Final Values): 0.016 (95% CI -0.535 to 0.568), p = 0.94, Regression, Linear

Population analysed: Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies). Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects)

Adverse events

Time frame: Participant enrollment to study completion, an average of 3 weeks for Phase 2A and 6 weeks for Phase 2B. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2A: Dronabinol Only	0 of 128 (0%)	13 of 128 (10.2%)	0 of 128
Phase 2A: Placebo Dronabinol Only	0 of 126 (0%)	6 of 126 (4.8%)	0 of 126
Phase 2B: Dronabinol and Ethanol	0 of 39 (0%)	7 of 39 (17.9%)	0 of 39
Phase 2B: Dronabinol and Placebo Ethanol	0 of 39 (0%)	12 of 39 (30.8%)	0 of 39
Phase 2B: Placebo Dronabinol and Ethanol	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
Phase 2B: Placebo Dronabinol and Placebo Ethanol	0 of 38 (0%)	4 of 38 (10.5%)	0 of 38

Limitations and caveats (from the sponsor): After reviewing and updating the study record to appropriately reflect the approved protocol, it was determined that the entry for Study Phase is best represented as N/A, rather than Phase 4, as the purpose of the study is NOT to investigate the safety or efficacy of the drug. This study seeks to use dronabinol only to probe and describe brain physiology. The change from Phase 4 to N/A more accurately and reflects the IRB approved protocol, and the aims of the grant that funds the research.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41615687Berchansky M, Evins AE, Evohr B, Himmelsbach Z, Pachas GN, Karunakaran KD, Laufer Goldshtein B, Ozana N, Gilman JM. Detection of Delta9-Tetrahydrocannabinol Impairment Using Resting-State Functional Near-Infrared Spectroscopy: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2556647. doi: 10.1001/jamanetworkopen.2025.56647.
Derived from this study: PubMed 38714786Karunakaran KD, Pascale M, Ozana N, Potter K, Pachas GN, Evins AE, Gilman JM. Intoxication due to Delta9-tetrahydrocannabinol is characterized by disrupted prefrontal cortex activity. Neuropsychopharmacology. 2024 Aug;49(9):1481-1490. doi: 10.1038/s41386-024-01876-5. Epub 2024 May 7.
Derived from this study: PubMed 34999737Gilman JM, Schmitt WA, Potter K, Kendzior B, Pachas GN, Hickey S, Makary M, Huestis MA, Evins AE. Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging. Neuropsychopharmacology. 2022 Mar;47(4):944-952. doi: 10.1038/s41386-021-01259-0. Epub 2022 Jan 8.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available

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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.

A. Eden Evins, MD, MPH principal investigator

Massachusetts General Hospital

Jodi M Gilman, PhD study director

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dronabinol and Ethanol in people with Intoxication Alcohol and Intoxication THC, run by Massachusetts General Hospital 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 8 inclusion and 11 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 28 Jul 2022. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 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?

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. (time frame: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.). 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 NCT03655717, which also lists 3 linked publications.

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 28 Jul 2022.