Psilocybin with Psychological Support (Psi-PS)... — Clinical Trial Details

Randomized, double-blind, placebo-controlled Phase II trial (n≈40) testing a single 25 mg oral dose of psilocybin (PEX010) plus nondirective psychological support versus inert placebo with identical psychological support in veterans and first responders with co-occurring AUD and PTSD.

Intervention includes two 60-minute telehealth preparation sessions, one 6–8 hour drug administration session with two facilitators present, and three 60-minute telehealth integration sessions; placebo recipients are offered open-label psilocybin at 4 weeks.

Primary objective is to characterise safety during the drug administration session and in follow-up to 24 weeks; secondary and exploratory measures assess subjective experience and clinical outcomes at multiple post-DAS timepoints.

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
1. Adults aged 21-65 who meet criteria for current DSM-5 diagnosis of AUD and PTSD as determined by the Alcohol System Checklist and CAPS-5.
2. Are either a US military Veteran or are currently employed as a first responder, including EMT, paramedic, firefighter, or law enforcement officer.
3. Report wanting to stop or decrease drinking and are willing to abstain from alcohol for the week prior to receiving any study drug.
4. Are English-speaking.
5. Must be willing to use contraception throughout the duration of the study. This applies to anyone, regardless of biological sex, who can cause pregnancy or become pregnant themselves.
6. Have a friend or family member who can pick them up and stay with them overnight after the DAS and who agrees to share contact information with the research team.
7. Have a primary care provider.
8. Have access to stable internet and either smart phone or computer.
9. Are willing to disclose medication use, supplement use, and interventions they are currently enrolled in; and commit to all study-related activities and follow-up sessions.
10. For the drug administration session, participants must be willing to reduce alcohol intake to be alcohol-free for 24 hours before DAS, fast after midnight before DAS, avoid caffeine and nicotine 2 hours before and 6-8 hours after DAS, and avoid driving for 24 hours post-DAS.
11. Must be locally accessible to the University of Washington for multiple in-person study visits.
12. Must have a friend or someone else the participant trusts to stay with them overnight for the evening following the DAS.

Exclusion Criteria

Exclusion Criteria:
1. A reported history of known medical conditions that would preclude safe participation in the trial, including the following:
* seizure disorder,
* coronary artery disease,
* history of arrhythmia or known valvopathy,
* heart failure,
* cerebrovascular accident,
* severe asthma
* pulmonary hypertension,
* hyperthyroidism,
* stenosing peptic ulcer,
* pyloroduodenal obstruction,
* symptomatic prostatic hypertrophy,
* bladder-neck obstruction.
2. Clinical findings on screening, including:
* significantly impaired liver function found in labs in prior 45-days or at screening
* uncontrolled hypertension (above 165/95 mmHg at screening)
* Serious ECG abnormalities measured at or within 45-days of screening (e.g., evidence of ischemia, myocardial infarction, QTc prolongation (QTc > 0.45 seconds for men, QTc > 0.47 seconds for women)).
3. Reported history or findings on SCID-CT of known exclusionary psychiatric conditions, including schizophrenia, schizoaffective disorder, bipolar disorder type I or type II.
4. A reported history of a serious suicide attempt (SSA) in previous 12-months.
5. A reported history of a personality disorder at time of screening.
6. A reported family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives).
7. Currently using SSRIs, SNRIs, MAOIs, TCAs, antipsychotics, lithium, stimulants, or other psychedelics.
8. Currently engaged in CBT, DBT, EMDR, psychoanalytic/psychodynamic therapy, MBSR, or unapproved group therapies, except for peer support groups.
9. Cognitive impairment (Folstein Mini Mental State Exam score < 26).
10. A reported lifetime history of hallucinogen use disorder (per DSM-5).
11. A reported history of cocaine, psychostimulant, or opioid use disorder defined by DSM-5 in the past 12 months, or currently utilizing full-agonist (methadone) or partial-agonist (buprenorphine) for OUD.
12. Current or historical abuse of psychedelic/hallucinogenic substances (e.g. LSD, mushrooms/psilocybin, mescaline/peyote, MDMA, ketamine, ayahuasca, ibogaine, DMT, etc.) endorsed by participant or suspected by the Lead Investigator's clinical judgement.

Company

Product

Legal

Psilocybin with Psychological Support (Psi-PS) for Military Veterans and First Responders with Co-occurring PTSD & Alcohol Use Disorder (AUD) (Psi-PS)

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details