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SuspendedPhase 2

Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002

NCT06816433 · Global Coalition for Adaptive Research

Closed to entry
Status
Not accepting participants
Phase 2
Phase
200
Target enrolment
9
Study sites
9 US states

What it is testing

Summary

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).

    Measured over 12 Weeks

  • Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.

    Measured over 12 Weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1. Is able to complete intranasal administration of study intervention. 2. Is able to refrain from alcohol or cannabis consumption/use on dosing days. 3. Is willing and able to attend dosing visits as outlined in the protocol (twice a week for the first 8 week and then once a week for Weeks 9 through 12) and agrees not to drive a car or operate machinery for 24 hours after receiving the study intervention. Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612). 1. Has a history of seizures (other than childhood febrile seizures). 2. Has a body mass index \>40 or \<18 kg/m2 at Screening. 3. Has known, uncontrolled hypertension or blood pressure that, in the investigator's judgment, should exclude the subject at Screening or Baseline (blood pressure may be repeated as per the site's standard operating procedures). 4. Has a known history or current finding of cardiovascular disease, cerebrovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, congenital heart disease, ischemic heart disease, cardiac insufficiency, supraventricular, ventricular heart rhythm disorder, prolonged QT syndrome (ie, QTcF \>450 msec for males and \>470 msec for females) or associated risk factors (ie, hypokalemia, family history of long QT syndrome), syncope, cardiac conduction problems (eg, clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, clinically significant bradycardia, or other serious cardiac problems. 5. Has a concurrent chronic or acute illness, or other condition (eg, narcolepsy, uncontrolled hyper- or hypothyroidism) that might confound the results of safety assessments conducted in the study. 6. Has any medical condition that could interfere with the absorption of intranasal ketamine (eg, nasal polyps, clinically significant deviated septum \[corrected or persistent\], or other physical abnormalities of the nose). 7. Has a history of interstitial or ulcerative cystitis, overactive bladder, painful bladder 8. syndrome, chronic pelvic pain, frequent recurrent urinary tract infections, autoimmune disease, active urinary tract infection, history of prostate cancer, bladder cancer or bladder a. surgery, or symptoms suggestive of these disorders (eg, high urinary frequency, persistent urge to urinate). 9. Has any history of using ketamine or esketamine. Note previous use of ketamine for anesthesia is allowed. 10. Has known or suspected intolerance or hypersensitivity to the study intervention(s), closely related compounds, or any ingredients. 11. Does not meet or is not willing to comply with the requirements listed in protocol related to prohibited and restricted medications and therapies, as well as required washout periods prior to participation. Prohibited medications and therapies include, but are not limited to, monoamine oxidase inhibitors (MAOIs), chronic/frequent use of opioids or drugs with activity at the opioid receptor, psychostimulants, mood stabilizers/anticonvulsants, antipsychotics, or any medication/therapy that might confound the results of safety assessments conducted in the study. Subjects who have received any of these prohibited medications within 30 days of Screening are excluded from the study. Potent CYP 3A4 inhibitors, including nefazodone and fluvoxamine, are not permitted within 1 week of first dose and until at least 1 day after the last dose. Potent CYP 3A4 inducers, including a. St. John's wort, are not permitted within 30 days of first dose and until at least 1 day after the last dose.

Where

9 study sites

FacilityCityRegionCountry
Homestead Associates in Research, Inc.MiamiFloridaUnited States
Advanced Discovery ResearchAtlantaGeorgiaUnited States
Tripler Army Medical Center (TAMC)Tripler AMCHawaiiUnited States
Cincinnati Veteran's Affairs Medical CenterFort ThomasKentuckyUnited States
Walter Reed National Military Medical Center (WRNMC)BethesdaMarylandUnited States
Upstate Clinical Research Associates, LLCWilliamsvilleNew YorkUnited States
Wilford Hall Ambulatory Surgical Center (WHASC)San AntonioTexasUnited States
Alexander T. Augusta Military Medical Center (ATAMMC):Fort BelvoirVirginiaUnited States
Madigan Army Medical CenterJoint Base Lewis McChordWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06816433 on ClinicalTrials.gov →

Last updated in the registry 2026-05-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits