Warrior CARE: Cannabis Behavioral Health
Purpose
This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.
Conditions
- Post Traumatic Stress Disorder
- Cannabis Use
- Suicide
- Veterans
- Marijuana
Eligibility
- Eligible Ages
- Between 19 Years and 69 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- a healthy veteran who has served in a branch of the US armed forces - report using cannabis within the past year - currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service) - between the ages of 19-69 years old - not seeking treatment for Cannabis Use Disorder - stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and/or psychotherapy before the study begins (participants can be in treatment for PTSD) - agree to adhere to study procedures
Exclusion Criteria
- pregnant, lactating, or heterosexually active women and not using medically approved birth control - current or past bipolar or psychotic disorder as determined using the SCID-5 - at immediate high risk for suicide based on the C-SSRS - current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate) - allergies and/or other contradictions for using cannabis - any clinically significant medical problems - systolic/diastolic BP >140/90 mmHg or systolic BP <95 mmHg - elevated liver function tests - exhibit cognitive impairment (<80 IQ) - enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing - used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results - unable to provide informed consent
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental THC Group |
Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC) |
|
|
Experimental CBD Group |
Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD) |
|
|
Experimental THC & CBD Group |
Cannabis with 5 mg THC and 5 mg CBD; up to a maximum of 5 doses/day (max doses = 25 mg THC and 25 mg CBD) |
|
|
Active Comparator Placebo Group |
Cannabis with <1mg THC and <1mg CBD; up to a maximum of 5 doses/day (max dose = <5 mg THC and <5 mg CBD) |
|
Recruiting Locations
Wayne State University
Detroit, Michigan 48201
Detroit, Michigan 48201
More Details
- Status
- Recruiting
- Sponsor
- Wayne State University
Detailed Description
In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to smoke their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.