State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
Purpose
The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.
Condition
- PTSD
Eligibility
- Eligible Ages
- Between 21 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Be a United States Military Veteran - Have at least a high-school level of education or equivalent (e.g. GED). - Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder - Have a CAPS-5 total severity score of ≥23 at baseline - SSRIs will be allowable so long as participants are on a stable regimen for a period of 3 months. - Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study. - Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests - No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
Exclusion Criteria
- General medical exclusion criteria: - Individuals who are pregnant or nursing; individuals who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control - Individuals with partners of childbearing potential who are sexually active and not practicing a highly effective means of contraception - Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged QTc interval (i.e., QTc > 450 msec), artificial heart valve, or TIA in the past year • Systolic blood pressure (SBP) > 139 mm HG; diastolic blood pressure (DBP) > 89 mm HG; heart rate (HR) > 90 bpm. - Epilepsy with history of seizures - Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of symptoms of hypoglycemia - Psychiatric Exclusion Criteria: - Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder - Current or history within six months of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; if a regular smoker, they must agree to use a nicotine patch on the day of dosing as smoking will not be allowed on these sessions - Have a first degree relative with schizophrenia spectrum or other psychotic disorders including substance/medication-induced or due to another medical condition - Risk for acute suicidality as determined by clinician judgment (C-SSRS) - Has a psychiatric condition which precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, history of significant stress-related paranoia, and identity disturbances - History of a medically significant suicide attempt - Current MAOI antidepressant use
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Psilocybin-assisted therapy |
Participants will enter a 5-week participation phase, which includes 3 preparatory sessions, 2 dosing days, and 4 integration sessions. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Baylor College of Medicine
