Warrior CARE: Cannabis Behavioral Health (CBH)

Wayne State University

Status and phase: Begins enrollment in 1 month; Phase 2; Phase 1

Conditions: Veterans; Post Traumatic Stress Disorder; Cannabis Use; Suicide; Marijuana

Treatments: Drug: Cannabidiol; Drug: Placebo; Drug: Tetrahydrocannabinol

Study type: Interventional

Funder types: Other

Identifiers

NCT06381180

Warrior CARE: CBH

Details and patient eligibility

About

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Full 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 vaporize 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• able to provide informed consent, IQ Score >80,
• served in branch of the US armed forces, report using cannabis,
• report using cannabis (no more than 2x in last month and no more than 100 lifetime use episodes)
• meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration

Exclusion criteria

• urine drug screen positive for any other drugs
• systolic/diastolic BP >140/90 mmHg?
• any clinically significant medical problems,
• any current or past serious psychotic or bipolar disorder diagnosis as determined by 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)
• pregnancy, lactating
• unable to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 4 patient groups

THC Group

Experimental group

Description:

Cannabis with 2.5 mg THC; up to a maximum of 5 doses/day (max dose = 12.5 mg THC)

Treatment:

Drug: Tetrahydrocannabinol

CBD Group

Experimental group

Description:

Cannabis with 2.5 mg CBD; up to a maximum of 5 doses/day (max dose = 12.5 mg CBD)

Treatment:

Drug: Cannabidiol

THC & CBD Group

Experimental group

Description:

Cannabis with 2.5 mg THC and 2.5 mg CBD; up to a maximum of 5 doses/day (max doses = 12.5 mg THC and 12.5 mg CBD)

Treatment:

Drug: Tetrahydrocannabinol

Drug: Cannabidiol

Placebo Group

Active Comparator group

Description:

Cannabis with \<1mg THC and \<1mg CBD; up to a maximum of 5 doses/day (max dose = \<5 mg THC and \<5 mg CBD)

Treatment:

Drug: Placebo