Phase 2 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between the ages of 21 and 65 who have been diagnosed with both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD), confirmed through standard assessment tools.
• People who are either a US military Veteran or currently working as a first responder, such as an EMT, paramedic, firefighter, or law enforcement officer.
• People who want to stop or reduce their drinking and are willing to avoid alcohol for one week before receiving any study medication.
• People who speak English.
• People who are willing to use contraception for the entire duration of the study — this applies to anyone who could cause a pregnancy or become pregnant, regardless of biological sex.
• People who have a trusted friend or family member who is able to pick them up after the drug session and stay with them overnight, and who agrees to share their contact information with the research team.
• People who have a primary care provider (a regular doctor).
• People who have reliable internet access and either a smartphone or a computer.
• People who are willing to share information about any medications, supplements, or other treatments they are currently using, and who are committed to attending all study activities and follow-up sessions.
• People who are willing to reduce alcohol intake to be fully alcohol-free for 24 hours before the drug session, not eat or drink after midnight before the session, avoid caffeine and nicotine for 2 hours before and 6–8 hours after the session, and avoid driving for 24 hours after the session.
• People who live close enough to the University of Washington to attend multiple in-person visits.
• People who have a trusted friend or family member available to stay with them overnight after the drug session.

Who may not be able to join:

• People with a known history of certain medical conditions, including seizure disorders, coronary artery disease, irregular heart rhythm or heart valve problems, heart failure, stroke, severe asthma, high blood pressure in the lungs, an overactive thyroid, certain stomach or digestive blockages, or urinary problems related to the prostate or bladder.
• People whose recent test results show seriously reduced liver function, uncontrolled high blood pressure (above 165/95 mmHg), or significant heart abnormalities on an ECG, such as signs of reduced blood flow to the heart or certain irregular electrical patterns.
• People who have a diagnosed or identified history of schizophrenia, schizoaffective disorder, or bipolar disorder type I or II, as confirmed through a structured clinical assessment.
• People who have had a serious suicide attempt in the past 12 months.
• People who have a diagnosed personality disorder at the time of screening.
• People with a family history of schizophrenia or schizoaffective disorder in a first- or second-degree relative, or bipolar disorder type I in a first-degree relative.
• People currently taking certain medications, including SSRIs, SNRIs, MAOIs, tricyclic antidepressants, antipsychotics, lithium, stimulants, or other psychedelic substances.
• People currently participating in certain types of structured psychological therapy, such as CBT, DBT, EMDR, psychoanalytic or psychodynamic therapy, mindfulness-based stress reduction (MBSR), or unapproved group therapies — though peer support groups are allowed.
• People whose results on a standard cognitive (thinking and memory) test fall below a certain level, indicating possible cognitive impairment.
• People with a lifetime history of hallucinogen use disorder, as defined by standard diagnostic criteria.
• People with a history of cocaine, psychostimulant, or opioid use disorder in the past 12 months, or who are currently taking methadone or buprenorphine for opioid use disorder.
• People with a current or past history of misusing psychedelic or hallucinogenic substances — such as LSD, psilocybin mushrooms, mescaline, MDMA, ketamine, ayahuasca, ibogaine, or DMT — either reported by the person or assessed by the lead investigator.
• People who have used cocaine, psychostimulants, psilocybin, or opioids for non-medical purposes in the past 30 days.
• People with a history of significant or severe alcohol withdrawal, including episodes of delirium, seizures, or hospitalisation related to alcohol withdrawal (people currently in withdrawal may be referred for detox and reassessed within 30 days).
• People whose recent blood test results show serious abnormalities in blood count or other chemical markers.
• People currently enrolled in any other clinical trial.
• People facing active legal issues that could result in imprisonment.
• People who are pregnant, breastfeeding, or intending to become pregnant or cause a pregnancy during the study.
• People who need to take medications that could significantly interact with the study drugs — such as antidepressants, antipsychotics, stimulants, addiction treatments, or other agents affecting certain brain chemical systems — as determined by the study physician or lead investigator.
• People with a known allergy or sensitivity to psilocybin.
• People assessed by the investigator as being at high risk of a difficult emotional or behavioural reaction, or considered unsuitable for other reasons identified by the research team.
• People who have previously been diagnosed with Hallucinogen Persisting Perception Disorder (HPPD), a condition where perceptual disturbances continue after hallucinogen use.
• People who have received an investigational drug or used an investigational medical device within the past 3 months (or within 5 half-lives of the drug), or who are currently in the treatment stage of another investigational study.

Important: Always verify eligibility with the trial site directly before applying.