Inhaled Cannabis for Treatment of PTSD
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Cave Creek, Arizona, United States, 85331
- Scottsdale Research Institute
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Contact:
- Principal Investigator
- Phone Number: 480-326-6023
- Email: ssisleymd@gmail.com
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Principal Investigator:
- Sue Sisley, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
a) 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.
b) 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.
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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
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Placebo contains <.01%
THC (NIDA Drug Supply)
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Experimental: Active Treatment
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dried flower of the Cannabis sativa or indica plant with high (18-22%) THC content
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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Intro 1 (Day 1), End of Treatment (Day 35)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compare changes in clinician-rated severity & improvement in the high THC vs placebo cannabis group as measured by the Clinical Global Impression Scale (CGI).
Time Frame: Intro 1 (Day 1), End of Treatment (Day 35)
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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. |
Intro 1 (Day 1), End of Treatment (Day 35)
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Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MJP2.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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