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 who have been diagnosed with Post-Traumatic Stress Disorder (PTSD), confirmed through a specific clinical assessment tool called the CAPS-5.
• People who have had a mild traumatic brain injury (TBI), confirmed through specific screening tools — this applies only to participants in the PTSD+TBI group.
• People who are able to provide at least two contact details (such as phone numbers or addresses) so they can be reached during the study.
• People who are able to give informed consent, meaning they can understand and agree to what the study involves.
• People who have a stable, reliable place to live.
• People who are willing to avoid all cannabis or cannabinoid products for the entire duration of the study.
• People who are willing to use contraception if there is any chance of becoming pregnant.

Who may not be able to join:

• People who have a history of an open head injury (where the skull was penetrated).
• People who had a traumatic brain injury within the last 6 months.
• People whose traumatic brain injury was moderate or severe.
• People who have had a substance use disorder in the past 12 months, except for mild alcohol use disorder or nicotine use.
• People who have used any cannabis or cannabinoid-containing product in the past month.
• People whose urine drug test comes back positive for cannabinoids, amphetamines, cocaine, or opioids.
• People who are currently taking medications that may interact with CBD (confirm with trial site).
• People with a lifetime history of a psychiatric disorder involving psychotic features, or a history of bipolar disorder.
• People who have been exposed to a traumatic event in the last 30 days, including through police or military service.
• People who have started psychotherapy for PTSD or another psychiatric condition within the 2 months before screening.
• People who have not been on a stable dose of certain medications for at least 2 months — this includes psychiatric medications, anti-seizure medications, blood pressure medications, stimulant-type medications, hormone replacement therapy, steroids, or medications linked to brain cell growth (confirm specific medications with trial site).
• People who have made an active suicide attempt in the past year.
• People who are currently assessed as having significant risk of suicide or harm to others, have had serious suicidal behaviour in the past 12 months, or have ever been hospitalised due to a serious suicide attempt.
• People who have a neurological condition or a body-wide illness that affects how the brain and nervous system function (not including TBI).
• People with a serious medical illness such as cancer or an infectious disease.
• People who have been diagnosed with anaemia or have been advised by a doctor not to have blood draws.
• People with significant abnormalities in liver function or blood and metabolic test results.
• People who have had a significant allergic reaction to cannabinoids or sesame oil.
• People who are currently pregnant or breastfeeding.
• People for whom MRI scanning is not safe (for example, due to certain metal implants).
• People who plan to try to conceive a child during the study or within two weeks of completing it.
• People who have active legal issues that are likely to result in imprisonment within 12 weeks of starting treatment.
• People assessed as being at high risk of a serious emotional or behavioural reaction during the study, such as those with a serious personality disorder, significant antisocial behaviour, major current life stressors, or a lack of social support.
• People who have received inpatient psychiatric treatment in the past 12 months, not including detox or extended emergency department stays.

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