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

ArmDescriptionAssigned Intervention
Experimental
THC Group 		Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)
  • Drug: Tetrahydrocannabinol
    Plant cannabis that will be smoked
    Other names:
    • THC
Experimental
CBD Group 		Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)
  • Drug: Cannabidiol
    Plant cannabidiol that will be smoked
    Other names:
    • 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)
  • Drug: Tetrahydrocannabinol
    Plant cannabis that will be smoked
    Other names:
    • THC
  • Drug: Cannabidiol
    Plant cannabidiol that will be smoked
    Other names:
    • 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)
  • Drug: Placebo
    Plant will be smoked.

Recruiting Locations

Wayne State University
Detroit, Michigan 48201
Contact:
Paula Qefaliaj, B.S.
2486881251
paulaq@wayne.edu

More Details

Status
Recruiting
Sponsor
Wayne State University

Study Contact

Leslie Lundahl, PhD
3139931374
llundahl@wayne.med.edu

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.