Methamphetamine Use DisorderPhase 2KARENCT06538285
Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV
A Phase 2 study testing Ketamine and Psychotherapy in people with Methamphetamine Use Disorder, run by Nicky Mehtani, MD, MPH at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at-risk for HIV disease. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Ketamine and Psychotherapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 14 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69
- Moderate or severe methamphetamine use disorder
- Interest in reducing or stopping methamphetamine use
- Insured by MediCal, MediCare, or Healthy San Francisco
- Used methamphetamine ≥7 out of the 30 days prior to screening OR enrolled in a residential drug treatment program
- Have a diagnosis of HIV OR taken PrEP over the last 90 days OR engaged in ≥1 risk behavior for HIV acquisition/transmission over the last 90 days (i.e., anal sex under the influence of methamphetamine, condomless sex with a partner of serodiscordant or unknown HIV status, or any shared use of injection drug supplies)
Show all 13Show fewer
- English speaking
- Permanently housed for ≥30 days OR enrolled in residential drug treatment for ≥5 days
- Have a text-capable cell phone or access to email (if not enrolled in residential treatment)
- Able and willing to provide informed consent and adhere to visit schedule
- If necessary, willing to be contacted on a daily basis by one of the therapists for 7 days after each ketamine session
- Prior to scheduled ketamine sessions, agree: (a) abstain from using methamphetamine and cocaine for ≥48 hours, (b) abstain from using non-prescribed opioids, cannabis products, benzodiazepines, or alcohol for ≥24 hours, (c) consume no more than a modest quantity (e.g., 1 cup) of caffeine (e.g., coffee or tea) in the morning; (d) continue usual regimen of routinely prescribed opioid-based medications throughout trial; and (e) continue any routine behavioral or pharmacologic mental health interventions as usual outside of the trial
- Female-born participants of child-bearing potential with male-born partners and male-born participants with female-born partners of child-bearing potential must agree to use highly effective contraception for at least 1 month prior to and 2 months after ketamine administration
Who cannot join
- Significant prior use of ketamine for non-anesthetic purposes, as determined by the investigators
- Cognitive impairment sufficient to impede the ability to complete study tasks
- Lifetime history of intracranial hemorrhage
- Has an intracranial mass
- Had a stroke in the past 12 months
- Had a seizure in the past 6 months
Show all 21Show fewer
- Has current psychosis or any lifetime history of schizophrenia or schizoaffective disorder
- Engaged in a contingency management program during study
- Taking any prohibited medications
- If receiving any medication that may cause blunting of responses or diminished affect, such as antipsychotics, exclusion will be as per the evaluation of the PI and study staff
- Active suicidal ideation with intent
- Baseline hypertension (≥150 SBP or ≥90 DBP) after repeated measurements
- History of aneurysmal vascular disease, dissection or arteriovenous malformation
- Had a cardiac arrest or myocardial infarction in the past 12 months
- QTc >450 msec on 12-lead EKG (Bazett's formula)
- Has a clinically significant arrhythmia
- Meets any of the following laboratory parameters: ALT ≥3x ULN, AST ≥3x ULN, total bilirubin ≥1.5x ULN, eGFR <30mL/min by CKD-EPI or currently on dialysis
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Pending legal proceedings with a high risk for incarceration during the study
- Taken another investigational drug in the past 30 days
- Has any physical or mental health condition which, per the clinical judgment of the investigators, interferes with safe study participation or adherence to study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francicso, California, 94102
About this study
Official title: Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at-risk for HIV disease. The main questions it aims to answer are:
- Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD?
- Is IM ketamine safe and tolerable among patients with MeUD?
Read more
Participants will:
- Receive 3 monitored doses of IM ketamine
- Have 3 preparation and 4 integration psychotherapy visits
- Report their daily amounts of methamphetamine used prior to, during, and up to 3 months following the intervention
Read the detailed description
This is a single-arm pilot feasibility trial (N=12) of 3 doses of ketamine hydrochloride (0.50-0.75 mg/kg IM) administered approximately once weekly, in combination with 7 sessions of manualized psychotherapy for publicly insured patients with moderate-to-severe methamphetamine use disorder (MeUD) who have or are at-risk for HIV. Participants will be administered 3 preparatory psychotherapy visits over the 14 days prior to their first ketamine visit, a psychotherapy integration visit within 1-3 days following each ketamine visit, and a final integration visit about 1 week following their last ketamine visit. This 10-visit Ketamine-Assisted Psychotherapy (KAP) treatment intervention will last about 5 weeks in duration, and 2 follow-up assessment visits will be conducted at 4 and 12 weeks following KAP.
Participants will receive ketamine 0.50 mg/kg IM during their initial dosing visit, and either ketamine 0.50 mg/kg IM or 0.75 mg/kg IM at each subsequent dosing visit, depending on their toleration of prior dose(s).
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Evaluations will be taken at baseline and each of the study visits.
The total duration of subject participation will be up to 119 days-including 5 weeks (i.e., 35 days) for the KAP intervention with follow-up assessment visits at 4 weeks (i.e., 28 days) and 12 weeks (i.e., 84 days) post-intervention.
The total duration of the study is expected to be 12 months.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Ketamine, Psychotherapy
- Keywords
- HIV, Methamphetamine withdrawal, Ketamine-assisted therapy, Psychedelic, Sexual Behavior, Methamphetamine, Ketamine-assisted psychotherapy, Chemsex
- Medical subject headings
- Sexual Behavior, Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar, Ketamine hydrochloride, Ketamine injection
Ketamine 0.50 mg/kg IM will be administered during the first dosing visit, and either 0.50 mg/kg IM or 0.75 mg/kg IM will be administered at the two subsequent dosing visits, depending on the participant's toleration of prior ketamine dose(s). All ketamine dosing visits will be facilitated by a licensed study therapist and clinician (i.e., NP or MD).
PsychotherapyBehavioural
Also called Talk therapy, Therapy
Psychotherapy will consist of three 1-hour preparatory talk therapy sessions over the 14 days preceding the first ketamine dosing visit, a 1-hour integration talk therapy session within 1-3 days following each ketamine dosing visit, and a final 1-hour integration talk therapy session about 1 week following the last ketamine visit. All talk therapy visits will be conducted by a licensed study therapist.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-Assisted Psychotherapy | Experimental | Participants will receive 3 administrations of intramuscular (IM) ketamine, dosed approximately once weekly, in combination with 7 psychotherapy visits over a 5-week treatment period. All ketamine dosing and psychotherapy visits will be conducted in-person in a designated therapy room. Receives: Drug: Ketamine; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Recruitment
Binary trial feasibility outcome of whether prospective participants undergoing in-person screening (V0) are found to be fully eligible and ultimately enroll in the study (V1).
Measured: Up to 28 days
Trial Completion
Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10)
Measured: Up to 35 days
Acceptability Questionnaire
At the end of the KAP intervention (i.e., V10), participants will be administered an 8-item, 5-point-scale questionnaire based off of the Sekhon Theoretical Framework of Acceptability to evaluate eight distinct aspects of the acceptability of the intervention. Higher scores indicate greater levels of intervention acceptability.
Measured: Up to 35 days
Secondary outcomes (11)
Adverse Events
Information regarding occurrence of adverse events will be captured throughout the study at every visit (i.e., V1-V12). Duration (start and stop dates), severity/grade, outcome, treatment and relation to study drug will be recorded.
Measured: Up to 119 days
Blood Pressure
During ketamine administration visits (i.e, V4, V6, and V8), blood pressure (in mmHg) will be monitored at serial 15-minute intervals for 60 minutes following ketamine dosing, and subsequently at 30-minute intervals until the session is complete.
Measured: Up to 28 days
Heart Rate
During ketamine administration visits (i.e, V4, V6, and V8), heart rate (in beats per minute) will be monitored at serial 15-minute intervals for 60 minutes following ketamine dosing, and subsequently at 30-minute intervals until the session is complete.
Measured: Up to 28 days
Methamphetamine Use by Timeline Follow Back
The TLFB is a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of substance use during a specified time period. It uses a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. The TLFB has shown adequate to excellent reliability and validity over a wide range of research and clinical contexts. Non-study SUD treatment utilization will also be recorded on the TLFB form.
Measured: Up to 119 days
Methamphetamine Cravings
A Visual Analog Scale (ranging from 0 to 100) will be used to assess participants' overall cravings for methamphetamine at every study visit.
Measured: Up to 119 days
Amphetamine Cessation Symptom Assessment
The ACSA is a 16-item, 5-point scale (0 = "Not at all" to 4 "Extremely") measuring various aspects of anxiety and mood, fatigue, and craving to measure the severity of amphetamine withdrawal symptoms over the past 24 hours. Higher scores reflect more severe withdrawal symptoms. The ACSA will be administered at all non-ketamine dosing visits (i.e., V1-V3, V5, V7, V9-V12).
Measured: Up to 119 days
Methamphetamine Positive Urine Drug Screens
A point-of-care urine drug screen (UDS) will be collected at every study visit (i.e., V1-V12).
Measured: Up to 119 days
Methamphetamine Levels in Hair
At baseline (V1), end-of-treatment (V10) and 4- and 12-weeks follow-up (V11 and V12), a 1-cm hair sample will be collected from the back of the scalp to measure cumulative drug levels of methamphetamine over the preceding one month period. Quantification of methamphetamine levels in hair will each require a sample of 50-100 strands, which is roughly the equivalent to the average amount of natural hair loss that occurs on a daily basis.
Measured: Up to 119 days
Antiretroviral Adherence
If applicable, self-reported days of antiretroviral drug adherence will be measured at baseline (i.e., V1), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12).
Measured: Up to 119 days
Depression Symptoms
The Patient Health Questionnaire-9 (PHQ-9) is a validated and widely-used 9-item, 4-point scale (0 = "Not at all" to 3 = "Nearly every day") that assesses depression symptom severity with a 2-week recall period. Higher scores indicate worse depression. It will be administered at baseline (V1), mid-KAP (V7), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12).
Measured: Up to 119 days
Anxiety Symptoms
The (GAD-7) is a validated self-report measure for the severity of generalized anxiety disorder (GAD) symptoms. This 7-item, 4-point scale (0 = "Not at all" to "3 = Nearly every day") scale has 2-week recall period. Item scores are summed to produce a total score that can range 0-21, with higher scores indicating greater severity of symptoms of GAD.
It will be administered at baseline (V1), mid-KAP (V7), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12).
Measured: Up to 119 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start4 Mar 2025
- Primary completion5 May 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicky Mehtani, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Department of Public Health, California HIV/AIDS Research Program, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Nicky Mehtani, MD, MPH, University of California, San Francisco
- Investigators
- Nicky Mehtani, MD MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538285
- Sponsor's protocol ID
- H24SB7788
- Other IDs
- 2KL2TR001870
- Acronym
- KARE
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehtani NJ, Anderson BT, Alexander I, Hendricks PS, Mitchell JM, Coffin PO, Johnson MO. Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks. BMJ Open. 2025 Aug 24;15(8):e100775. doi: 10.1136/bmjopen-2025-100775.
PubMed 40850924
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
- ClinicalTrials.gov ID
- NCT06538285
- Acronym / sponsor ID
- KARE / H24SB7788
- Conditions
- Methamphetamine Use Disorder
- Keywords
- HIV, Methamphetamine withdrawal, Ketamine-assisted therapy, Psychedelic, Sexual Behavior, Methamphetamine, Ketamine-assisted psychotherapy, Chemsex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nicky Mehtani, MD, MPHUniversity, hospital or other
- Collaborators
- San Francisco Department of Public Health, California HIV/AIDS Research Program, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at-risk for HIV disease. The main questions it aims to answer are:
- Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD?
- Is IM ketamine safe and tolerable among patients with MeUD?
Participants will:
- Receive 3 monitored doses of IM ketamine
- Have 3 preparation and 4 integration psychotherapy visits
- Report their daily amounts of methamphetamine used prior to, during, and up to 3 months following the intervention
Detailed description
This is a single-arm pilot feasibility trial (N=12) of 3 doses of ketamine hydrochloride (0.50-0.75 mg/kg IM) administered approximately once weekly, in combination with 7 sessions of manualized psychotherapy for publicly insured patients with moderate-to-severe methamphetamine use disorder (MeUD) who have or are at-risk for HIV. Participants will be administered 3 preparatory psychotherapy visits over the 14 days prior to their first ketamine visit, a psychotherapy integration visit within 1-3 days following each ketamine visit, and a final integration visit about 1 week following their last ketamine visit. This 10-visit Ketamine-Assisted Psychotherapy (KAP) treatment intervention will last about 5 weeks in duration, and 2 follow-up assessment visits will be conducted at 4 and 12 weeks following KAP.
Participants will receive ketamine 0.50 mg/kg IM during their initial dosing visit, and either ketamine 0.50 mg/kg IM or 0.75 mg/kg IM at each subsequent dosing visit, depending on their toleration of prior dose(s).
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Evaluations will be taken at baseline and each of the study visits.
The total duration of subject participation will be up to 119 days-including 5 weeks (i.e., 35 days) for the KAP intervention with follow-up assessment visits at 4 weeks (i.e., 28 days) and 12 weeks (i.e., 84 days) post-intervention.
The total duration of the study is expected to be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine-Assisted Psychotherapy | Experimental | Drug: Ketamine, Behavioral: PsychotherapyParticipants will receive 3 administrations of intramuscular (IM) ketamine, dosed approximately once weekly, in combination with 7 psychotherapy visits over a 5-week treatment period. All ketamine dosing and psychotherapy visits will be conducted in-person in a designated therapy room. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-69
- Moderate or severe methamphetamine use disorder
- Interest in reducing or stopping methamphetamine use
- Insured by MediCal, MediCare, or Healthy San Francisco
- Used methamphetamine ≥7 out of the 30 days prior to screening OR enrolled in a residential drug treatment program
Key exclusion criteria (21 listed)
- Significant prior use of ketamine for non-anesthetic purposes, as determined by the investigators
- Cognitive impairment sufficient to impede the ability to complete study tasks
- Lifetime history of intracranial hemorrhage
- Has an intracranial mass
- Had a stroke in the past 12 months
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 |
|---|---|---|
| KetamineAlso: Ketalar, Ketamine hydrochloride, Ketamine injectionKetamine 0.50 mg/kg IM will be administered during the first dosing visit, and either 0.50 mg/kg IM or 0.75 mg/kg IM will be administered at the two subsequent dosing visits, depending on the participant's toleration of prior ketamine dose(s). All ketamine dosing visits will be facilitated by a licensed study therapist and clinician (i.e., NP or MD). | Drug | Ketamine-Assisted Psychotherapy |
| PsychotherapyAlso: Talk therapy, TherapyPsychotherapy will consist of three 1-hour preparatory talk therapy sessions over the 14 days preceding the first ketamine dosing visit, a 1-hour integration talk therapy session within 1-3 days following each ketamine dosing visit, and a final 1-hour integration talk therapy session about 1 week following the last ketamine visit. All talk therapy visits will be conducted by a licensed study therapist. | Behavioural | Ketamine-Assisted Psychotherapy |
Primary outcome
Trial Recruitment
Time frame: Up to 28 days
Binary trial feasibility outcome of whether prospective participants undergoing in-person screening (V0) are found to be fully eligible and ultimately enroll in the study (V1).
Trial Completion
Time frame: Up to 35 days
Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10)
Acceptability Questionnaire
Time frame: Up to 35 days
At the end of the KAP intervention (i.e., V10), participants will be administered an 8-item, 5-point-scale questionnaire based off of the Sekhon Theoretical Framework of Acceptability to evaluate eight distinct aspects of the acceptability of the intervention. Higher scores indicate greater levels of intervention acceptability.
11 secondary outcomes
Adverse Events
Time frame: Up to 119 days
Blood Pressure
Time frame: Up to 28 days
Heart Rate
Time frame: Up to 28 days
Methamphetamine Use by Timeline Follow Back
Time frame: Up to 119 days
Methamphetamine Cravings
Time frame: Up to 119 days
Amphetamine Cessation Symptom Assessment
Time frame: Up to 119 days
Methamphetamine Positive Urine Drug Screens
Time frame: Up to 119 days
Methamphetamine Levels in Hair
Time frame: Up to 119 days
Antiretroviral Adherence
Time frame: Up to 119 days
Depression Symptoms
Time frame: Up to 119 days
Anxiety Symptoms
Time frame: Up to 119 days
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 12 Aug 2026.
- Derived from this study: PubMed 40850924Mehtani NJ, Anderson BT, Alexander I, Hendricks PS, Mitchell JM, Coffin PO, Johnson MO. Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks. BMJ Open. 2025 Aug 24;15(8):e100775. doi: 10.1136/bmjopen-2025-100775.
- Individual participant dataSharing planned: No
Related trials for Methamphetamine Use Disorder
Active, not recruiting
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
Methamphetamine Use Disorder
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Not yet recruiting
Closed-loop TMS for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
Active, not recruiting
Closed-loop TBS Targeting rPO for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
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.
Nicky Mehtani, MD MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Psychotherapy in people with Methamphetamine Use Disorder, run by Nicky Mehtani, MD, MPH 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 13 inclusion and 21 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial Recruitment (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538285, which also lists 1 linked publication.
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 12 Aug 2026.