Clinical TrialPTSDPsilocybinUnknown status

Northwest Therapies Trauma Psilocybin Study Compassionate Use Study

Phase I single-group intervention (n=30) evaluating enhanced psilocybin microdosing (0.15–0.33 g dosing; monthly 1–1.5 g maintenance) for chronic conditions including PTSD, chronic depression, MS, HIV and Long COVID.

Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Non-randomized, triple Blind

Detailed Description

This single-group Phase I study evaluates a tailored enhanced microdosing regimen of non-synthetic psilocybin delivered orally to participants with chronic illness (including PTSD, chronic depression, MS, HIV and SARS-CoV-2 long-haul syndrome) over an eight-week course with monthly maintenance dosing.

Participants are onboarded and monitored by a multidisciplinary team (psychiatrist, LCPC therapist, Plant Medicine On-Boarding Provider) who will tailor dosing and manage reduction of concurrent SSRIs where clinically appropriate; outcomes include feasibility, safety, and measures of symptom change and quality of life.

Study Protocol

Preparation

sessions

Dosing

27 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Enhanced microdose psilocybin

experimental

Tailored enhanced microdosing schedule with monthly maintenance dose; single-group treatment protocol.

Interventions

  • Psilocybin0.33 - 1.5 g
    via Oral• Initial every-other-day then M/W/F for 8 weeks; monthly maintenance

    Enhanced microdosing 0.15–0.33 g (typical up to 0.33 g); monthly single maintenance dose 1–1.5 g; dose tailored by PMOP/psychiatrist.

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participants must have a diagnosis of one of the following chronic conditions: Trauma, PTSD, Unregulated Chronic Depression, MS, HIV, Cancer, or SARS-CoV-2 Long Haulers Syndrome.
  • Participants must provide informed consent and will be onboarded by study staff (Psychiatrist, LCPC Therapist, Administrator, Plant Medicine On-Boarding Provider).

Exclusion Criteria

  • Exclusion Criteria:
  • Cardiovascular complications (as assessed by study clinician).

Study Details

  • Status
    Unknown status
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomizedtriple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2023-09-03
    End: 2025-10-03
  • Compound
    Psilocybin
  • Topic
    PTSD

Locations

Ross Allison NPI #1437519899 Administrator Of Study — Bozeman, Montana, United States

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