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:

• People aged 18 to 55 at the time of joining, who are reproductively mature and speak English.
• People who have been diagnosed with chronic PTSD, meaning their PTSD has lasted more than 3 months, as confirmed by a clinical assessment tool called the CAPS-5.
• People who are generally in good health and are not taking any medications that could interfere with the study.
• People who are willing to avoid alcohol for 2 weeks, and avoid nicotine, marijuana, and illicit drugs for 4 weeks before the study procedures, and throughout the study.
• Biological females with a natural (non-hormone-controlled) menstrual cycle.
• Biological females who could become pregnant must use 2 forms of effective birth control (hormonal contraceptives are not allowed unless it is a hormonal IUD such as Mirena, or a vaginal ring device such as Nuvaring) for one week before the study infusion and for one month after.

Who may not be able to join:

• People who pose an immediate risk of harm to themselves or others, or who need active clinical support to stay safe.
• People diagnosed with a moderate or severe substance use disorder within the past 3 months. A mild substance use disorder within the past 3 months may not be automatically disqualifying if the person agrees to abstain from relevant substances, passes follow-up drug and alcohol tests, and tests clear on the morning of study procedures (confirm with trial site).
• People diagnosed with Bipolar I disorder, schizophrenia-related disorders, or significant psychotic symptoms — except for hallucinations or negative thoughts directly related to trauma.
• People who have attempted suicide within the past year.
• People with a history of severe traumatic brain injury (for certain parts of the study), or a history of moderate or severe traumatic brain injury (for the main study experiments) (confirm with trial site for which applies).
• People diagnosed with sleep apnea.
• People whose blood oxygen level while awake and at rest is below 96%.
• People with severe kidney disease, where kidney filtration is measured below a certain level.
• People currently using illicit substances, or taking prescribed opioids or benzodiazepines detected at screening.
• People with a positive alcohol test at medical screening, which may indicate significant alcohol dependence.
• People taking over-the-counter or prescription medications that could interfere with the study drug or increase the risk of side effects, unless those medications can be safely stopped under a doctor's supervision within the required timeframe (confirm with trial site).
• People taking systemic hormonal contraceptives on the day of study procedures — hormonal IUDs (such as Mirena, Kyleena, Liletta, or Skyla) or vaginal ring devices (such as Nuvaring) may be allowed if normal menstrual cycles and ovulation are confirmed (confirm with trial site).
• People who are currently pregnant (pregnancy tests are given at each in-person visit).
• People who are currently breastfeeding.
• People who are unable to tolerate having an intravenous (IV) line placed or having blood drawn by needle.
• People who wear hearing aids (for the main study experiments, but not the other parts of the study).
• People who do not pass a hearing test (for the main study experiments, but not the other parts of the study).

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