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:

For all participants:

• You are willing and able to give your consent to take part in the study
• You are willing to follow all study procedures and are available for the full length of the study
• You are between 21 and 65 years old
• You are able to read and communicate in English
• You use cannabis (marijuana/THC) on fewer than 3 days per week

For people with PTSD:

• You have been diagnosed with PTSD according to current medical guidelines, with symptoms lasting at least 1 month
• Your PTSD symptoms score at or above a certain level on a standard assessment scale at the time you join the study (confirm with trial site)
• You have been on a stable mental health medication or therapy program for at least 4 weeks before joining

Who may not be able to join:

For all participants:

• You are currently using any prescribed or over-the-counter CBD products (including the medication Epidiolex®)
• You have had recent serious thoughts of suicide or made a suicide attempt within the past 6 months, as measured by a standard assessment tool
• You have a thinking or memory problem that the study doctor believes would affect your ability to complete the study
• You have had a moderate or serious problem with drug or alcohol use in the past 6 months (tobacco/nicotine use is allowed)
• You have been using cannabis more than 3 days per week in the 4 weeks before joining
• Your urine drug test comes back positive for any illegal substances other than cannabis
• You are pregnant (confirmed by a blood test) or currently breastfeeding
• You have a serious medical condition or are taking certain medications that the study doctor believes could make it unsafe for you to participate (confirm with trial site)
• You have taken part in another research drug study or treatment trial within the past 3 months
• You have a history of psychosis, active bipolar disorder, or borderline personality disorder diagnosed by a mental health professional
• You have a history of an open head injury (a brain injury where the skull was broken)
• You experienced a traumatic event within the past 30 days
• You are currently on active military duty within the past 30 days
• You have been admitted to a psychiatric hospital within the past 6 months
• You have had a seizure in the past 6 months
• You are currently taking HIV antiviral medications (note: PrEP, a medication to prevent HIV, is allowed)

For people without PTSD (control participants):

• You have a previous diagnosis of PTSD
• You are pregnant (by self-report) or currently breastfeeding

For participants who agree to have an MRI brain scan:

• You have claustrophobia (fear of enclosed spaces), are pregnant, or have a condition the study doctor believes would make an MRI unsafe for you
• You have any metal objects in or on your body, such as a pacemaker, metal implants, certain dental devices, cochlear implants, non-removable piercings, or metal fragments in your body
• You have another medical condition the study doctor believes would interfere with the MRI scan (confirm with trial site)

Additional exclusions for people with PTSD:

• Your only traumatic experience happened before the age of 18 and you have had no other traumas that could be connected to your PTSD
• You have had an allergic reaction or serious side effects related to cannabis, CBD, or THC in the past
• You are currently in a situation that is actively causing your PTSD
• Your liver function blood test results are significantly above the normal range at the time of screening
• If you are able to become pregnant, you are not willing to use at least one form of birth control throughout the study (acceptable methods include condoms, diaphragm, abstinence, or hormonal/implanted contraception such as the pill, injection, or IUD)

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