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Post Traumatic Stress Disorder PTSDPhase 2NCT07224698

Inhaled Cannabis for Treatment of PTSD

A Phase 2 study testing High THC Cannabis in people with Post Traumatic Stress Disorder PTSD, run by Multidisciplinary Association for Psychedelic Studies.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Traumatic Stress Disorder PTSD
What is being tested?
High THC Cannabis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
No sites listed yet
Study dates
Feb 2027to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • A participant is eligible to participate if not pregnant, and one of the following conditions applies: i) Is not able to become pregnant as defined in protocol (Appendix 2) OR ii) Is a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in the protocol (Appendix 2) during the study intervention period and for at least 14 days after the Study Termination visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
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  • A PABP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening, Introductory Session 1, Resupply, and EoT visits c) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.
  • 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).
  • Be willing to commit to medication dosing and delivery method, to complete evaluation instruments, and attend all study visits.
  • Agree to use only cannabis provided by site staff and agree to required follow up periods for the duration of the study.
  • Agree to keep all cannabis provided by site staff securely stored in the provided lock box and not to share/distribute cannabis to any other individual.
  • Be proficient in reading and writing in English and able to effectively communicate with site staff.
  • Agree not to participate in any other interventional clinical trials during the study.
  • Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
  • Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
  • Must be able and willing to record information digitally on a personal device (phone or computer) with internet access.

Who cannot join

  • 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.
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  • 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
  • Have a history of arrhythmia, other than occasional premature atrial contractions (PACs) and PVCs in the absence of ischemic heart disease, within 12 months of screening.
  • Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist.
  • Have a current or history of chronic obstructive pulmonary disease or asthma.
  • Have a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, hepatic, immunocompromising, or neurological disease according to CI's discretion.
  • Have any current problem or presence of clinical feature which, in the opinion of the CI or Medical Monitor, might interfere with or prevent appropriate study participation.
  • Have any known allergies to cannabis or contraindication for inhalation of cannabis.
  • Are not able to give adequate informed consent.
  • Insufficient ability to report on symptoms to make a valid assessment on any required instrument.
  • Are not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.

About this study

Official title: Phase 2 Multicenter Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of Inhaled Cannabis in Veterans for Treatment of Posttraumatic Stress Disorder (PTSD)

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.

Being tested
High THC Cannabis, Placebo cannabis
Keywords
PTSD, Veteran, cannabis, inhaled cannabis, THC, posttraumatic stress disorder, Veteran Affairs
Medical subject headings
Combat Disorders, Stress Disorders, Post-Traumatic, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High THC CannabisDrug

    dried flower of the Cannabis sativa or indica plant with high (18-22%) THC content

  • Placebo cannabisDrug

    Placebo contains <.01% THC (NIDA Drug Supply)

Study groups in NCT07224698
Study groupRoleWhat they receive
Active TreatmentExperimentalNot described
Receives: Drug: High THC Cannabis
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    The CAPS-5 is a 30-item semi-structured interview assessing PTSD in the past month through diagnostic and symptom severity scores anchored to a DSM-5 defined traumatic event. The CAPS-5 produces a Total Severity Score based on severity of PTSD domains described in the DSM-5, as well as a categorical rating indicating whether a participant meets PTSD diagnostic criteria. CAPS-5 Total Symptom Severity scores range from 0 to 80 with higher values indicating greater symptom severity. CAPS-5 assigns PTSD diagnosis as being present or absent.

    Measured: Intro 1 (Day 1), End of Treatment (Day 35)

Secondary outcomes (1)

  1. Compare changes in clinician-rated severity & improvement in the high THC vs placebo cannabis group as measured by the Clinical Global Impression Scale (CGI).

    The Clinical Global Impression (CGI) scale is a widely used 3-item clinician-rated measure of overall illness severity and change over time. It consists of two components: the CGI-Severity (CGI-S), which assesses the clinician's impression of the participant's current illness severity, and the CGI-Improvement (CGI-I), which assesses change relative to baseline. Ratings are based on the clinician's global clinical judgment, informed by all available clinical information.

    In this study, the CGI will be completed by the site clinician at Baseline and End of Treatment. The CGI-S will be used to characterize baseline clinical severity, and the CGI-I will be used to assess overall clinical improvement over the course of treatment. The CGI is widely used in psychiatric research, is non-proprietary, and requires minimal administration time.

    Measured: Intro 1 (Day 1), End of Treatment (Day 35)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2025
  2. Study startFeb 2027 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224698
Sponsor's protocol ID
MJP2.
Status last verified
Aug 2026
First submitted
3 Nov 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High THC Cannabis in people with Post Traumatic Stress Disorder PTSD, run by Multidisciplinary Association for Psychedelic Studies.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Intro 1 (Day 1), End of Treatment (Day 35)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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