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New treatment option for PTSD
Official title State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
ClinicalTrials.gov ID: NCT06888128
What this study is testing
What is Psilocybin 15mg?
Psilocybin 15mg is an investigational medicine, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 64
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of symptoms of hypoglycemia
See the full eligibility 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...
- No use of hallucinogens in the past 3 months and no history of regular or frequent use of hallucinogens
- 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)...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.