Opioid UsePhase 1NCT04315181

Prescription Medication Interactions

A Phase 1 study testing Opioid Agonist and Sedatives in people with Opioid Use and Sedative Use, run by Sharon Walsh 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

This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Opioid Use, Sedative Use
What is being tested?: Opioid Agonist and Sedatives
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 25 Mar 2019to 6 May 2023
Phase: Phase 1
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
No healthy volunteers
Adult

Who may be able to join

Healthy adults, ages 18-55
Current non-medical use of opioids and sedatives

Who cannot join

Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
Seeking treatment for drug use
Significant medical problems

Trial locations and contacts

1 site in 1 country.

United States1 site

Center on Drug and Alcohol Research
Lexington, Kentucky, 40508

Other trials in United States

About this study

Official title: Prescription Medications: Pharmacodynamics and Interaction Effects

Read the detailed description

Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature of gabapentin's abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or another opioid agonist) and gabapentin in combination. This study's objective is to characterize the subjective effect profile of gabapentin, examine the interaction between gabapentin and oxycodone, and assess the acute analgesic response to gabapentin and oxycodone, alone and in combination, across a range of doses for each drug.

Conditions: Opioid Use, Sedative Use
Being tested: Opioid Agonist, Sedatives
Keywords: opioid, sedative, opiate

What participants receive

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

Opioid AgonistDrug
Abuse liability evaluation.
SedativesDrug
Abuse liability evaluation.

Study groups in NCT04315181
Study group	Role	What they receive
Placebo / Placebo	Placebo comparator	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Placebo / Oxycodone 20mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Placebo / Oxycodone 40mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 600mg / Placebo	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 1200mg / Placebo	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 600mg / Oxycodone 20mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 1200mg / Oxycodone 20mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 600mg / Oxycodone 40mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives
Gabapentin 1200mg / Oxycodone 40mg	Experimental	Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. Receives: Drug: Opioid Agonist; Drug: Sedatives

What is being measured

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

Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects.
Measured: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Secondary outcomes (4)

Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect
Participants rated their subjective drug effect on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects.
Measured: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Respiration Rate
Respiration rate (number of breaths per minute). Raw data transformed to trough scores. Lower scores indicate greater impairment.
Measured: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in End-tidal Carbon Dioxide (EtCO2)
EtCO2 collected via capnograph monitored throughout each session. Raw data transformed to peak scores. Higher scores indicate greater impairment.
Measured: EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Oxygen Saturation
Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Raw data transformed to trough scores. Lower scores indicate greater impairment.
Measured: Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Timeline

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

25 Mar 20196 May 2023

First posted19 Mar 2020
Study start25 Mar 2019
Primary completion6 May 2023
Study completion6 May 2023

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 Opioid UseStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04315181
Sponsor's protocol ID: 46591
Other IDs: R01DA016718
Status last verified: Oct 2025
First submitted: 17 Mar 2020
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: We have no plans to share individual participant data with other researchers.

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 Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prescription Medications: Pharmacodynamics and Interaction Effects
ClinicalTrials.gov ID: NCT04315181
Acronym / sponsor ID: 46591
Conditions: Opioid Use, Sedative Use
Keywords: opioid, sedative, opiate
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Sharon WalshUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 25 Mar 2019 (actual)
Primary completion: 6 May 2023 (actual)
Study completion: 6 May 2023 (actual)
First posted: 19 Mar 2020 (actual)
Results: Posted 27 Jun 2024

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: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Placebo / Placebo	Placebo comparator	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Placebo / Oxycodone 20mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Placebo / Oxycodone 40mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 600mg / Placebo	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 1200mg / Placebo	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 600mg / Oxycodone 20mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 1200mg / Oxycodone 20mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 600mg / Oxycodone 40mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Gabapentin 1200mg / Oxycodone 40mg	Experimental	Drug: Opioid Agonist, Drug: SedativesParticipants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy adults, ages 18-55
Current non-medical use of opioids and sedatives

Key exclusion criteria (3 listed)

Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
Seeking treatment for drug use
Significant medical problems

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
Opioid AgonistAbuse liability evaluation.	Drug	Gabapentin 1200mg / Oxycodone 20mg, Gabapentin 1200mg / Oxycodone 40mg, Gabapentin 1200mg / Placebo, Gabapentin 600mg / Oxycodone 20mg, Gabapentin 600mg / Oxycodone 40mg, Gabapentin 600mg / Placebo, Placebo / Oxycodone 20mg, Placebo / Oxycodone 40mg, Placebo / Placebo
SedativesAbuse liability evaluation.	Drug	Gabapentin 1200mg / Oxycodone 20mg, Gabapentin 1200mg / Oxycodone 40mg, Gabapentin 1200mg / Placebo, Gabapentin 600mg / Oxycodone 20mg, Gabapentin 600mg / Oxycodone 40mg, Gabapentin 600mg / Placebo, Placebo / Oxycodone 20mg, Placebo / Oxycodone 40mg, Placebo / Placebo

Primary outcome

Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects.

4 secondary outcomes

Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect
Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Respiration Rate
Time frame: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in End-tidal Carbon Dioxide (EtCO2)
Time frame: EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Oxygen Saturation
Time frame: Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Results and safety

Results posted to the registry on 27 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prescription Medication Interactions	11	10

Primary outcome: Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking

Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).. Mean (Standard Error). Unit: Score on a scale

Measure	Placebo / Placebo n = 10	Placebo / Oxycodone 20mg n = 10	Placebo / Oxycodone 40mg n = 10	Gabapentin 600mg / Placebo n = 10	Gabapentin 1200mg / Placebo n = 10	Gabapentin 600mg / Oxycodone 20mg n = 10	Gabapentin 1200mg / Oxycodone 20mg n = 10	Gabapentin 600mg / Oxycodone 40mg n = 10	Gabapentin 1200mg / Oxycodone 40mg n = 10
Value	7.40 (2.39)	39.00 (7.19)	40.80 (9.14)	24.50 (8.54)	15.00 (8.70)	40.70 (9.10)	34.50 (8.26)	56.50 (6.85)	44.90 (8.29)

Placebo / Placebo vs Placebo / Oxycodone 20mg vs Placebo / Oxycodone 40mg vs Gabapentin 600mg / Placebo vs Gabapentin 1200mg / Placebo vs Gabapentin 600mg / Oxycodone 20mg vs Gabapentin 1200mg / Oxycodone 20mg vs Gabapentin 600mg / Oxycodone 40mg vs Gabapentin 1200mg / Oxycodone 40mg: p <0.0001, Mixed Models Analysis

Population analysed: Per Protocol population, defined as participants completing the 9 experimental drug conditions.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 6 weeks. AE monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Intervention / Days Off	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Qualification: Placebo / Oxycodone 30mg	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Placebo / Placebo	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Placebo / Oxycodone 20mg	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Placebo / Oxycodone 40mg	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Gabapentin 600mg / Placebo	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Gabapentin 1200mg / Placebo	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Gabapentin 600mg / Oxycodone 20mg	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Gabapentin 1200mg / Oxycodone 20mg	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Gabapentin 600mg / Oxycodone 40mg	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Gabapentin 1200mg / Oxycodone 40mg	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We have no plans to share individual participant data with other researchers.

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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.

Sharon L Walsh, Ph.D. principal investigator

University of Kentucky

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Opioid Agonist and Sedatives in people with Opioid Use and Sedative Use, run by Sharon Walsh 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 2 inclusion and 3 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 20 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 27 Jun 2024). 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 Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking (time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).). 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 NCT04315181.

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 20 Oct 2025.