Inhaled Cannabis for Treatment of PTSD

ConditionPost Traumatic Stress Disorder PTSD

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMultidisciplinary Association for Psychedelic Studies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

High THC Cannabis
Drug
dried flower of the Cannabis sativa or indica plant with high (18-22%) THC content
Placebo cannabis
Drug
Placebo contains \<.01% THC (NIDA Drug Supply)

Treatment groups

320 Participants

are divided into 2 treatment groups

Group A: Active TreatmentExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Multidisciplinary Association for Psychedelic Studies

Lead sponsor

Changemark Research + Evaluation Ltd.

Collaborator

Source ClinicalTrials.gov

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