Inhaled Cannabis for Treatment of PTSD (NCT07224698) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Inhaled Cannabis for Treatment of PTSD
320 participantsStarted 2027-02
Plain-language summary
The rationale for the use of inhalational cannabis to potentially treat PTSD symptoms is based on the many reports of cannabis attenuating PTSD symptom expression among individuals with PTSD, including veterans. Study MJP2 is intended to build off MJP-1 through use of a larger sample size, a parallel study design, and subjective bias mitigation methods to re-examine the use of inhaled high THC-containing cannabis versus placebo for management of PTSD symptoms in a U.S. Veteran sample. Together these studies are intended to provide valuable insights on the already widespread use of cannabis in individuals with PTSD, for which there is currently a lack of controlled evidence available reflective of this real-world use.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be at least 18 years old.
. Be a veteran with PTSD lasting 6 months in duration.
. Meet DSM-5 criteria for PTSD with symptoms
. Have PTSD of at least moderate severity at the time of screening.
. For participants assigned female sex at birth:
. Be stable on any pre-study medications and/or psychotherapy prior to study entry, agree to inform physician(s)/clinician(s) providing current care about participation in the study, and agree to report any changes in medication or psychotherapy treatment regimen during the study-to-study staff.
. Have previously inhaled cannabis (e.g. smoked or vaporized cannabis).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy: Compare changes in PTSD symptom severity in the high THC vs placebo cannabis group as measured by Clinician Administered PTSD Scale for DSM-5, Revised (CAPS-5-R).
Timeframe: Intro 1 (Day 1), End of Treatment (Day 35)
Trial details
NCT IDNCT07224698
SponsorMultidisciplinary Association for Psychedelic Studies
. Be willing to commit to medication dosing and delivery method, to complete evaluation instruments, and attend all study visits.
Exclusion criteria
. Are pregnant, nursing, or are a person able to become pregnant who are not practicing an effective means of birth control.
. Have current major depressive disorder with primary psychotic features
. Have current or past DSM-5 diagnosis of eating disorder with active purging, personality disorders, primary psychotic disorder, or bipolar affective disorder type 1
. Have current or past DSM-5 diagnosis of dissociative identity disorder, positive family history (first degree relative) of psychotic disorder or bipolar affective disorder type 1
. Are at high risk of suicide attempt: any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled.
. Would present serious risk to others as established by clinical interview and contact with treating psychiatrist.
. Have a current moderate or severe alcohol or cannabis use disorder within the 12 months prior to enrollment. Participants with a substance use disorder other than alcohol or cannabis are excluded.
. Have a positive urine drug screen for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with a positive THC urine analysis test are excluded from the study, but will be allowed to rescreen once after a 1-month cessation of cannabis use