Warrior CARE: Cannabis Behavioral Health

NCT ID: NCT06381180

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2030-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THC Group

Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)

Group Type: EXPERIMENTAL

Tetrahydrocannabinol

Intervention Type: DRUG

Plant cannabis that will be smoked

CBD Group

Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Plant cannabidiol that will be smoked

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)

Group Type: EXPERIMENTAL

Tetrahydrocannabinol

Intervention Type: DRUG

Plant cannabis that will be smoked

Cannabidiol

Intervention Type: DRUG

Plant cannabidiol that will be smoked

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)

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Plant will be smoked.

Interventions

Tetrahydrocannabinol

Plant cannabis that will be smoked

Intervention Type: DRUG

Cannabidiol

Plant cannabidiol that will be smoked

Intervention Type: DRUG

Placebo

Plant will be smoked.

Intervention Type: DRUG

Other Intervention Names

THC; CBD

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Leslie Lundahl

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

Central Contacts

Leslie Lundahl, PhD

Role: CONTACT

llundahl@wayne.med.edu

3139931374

Paula Qefaliaj, B.S.

Role: CONTACT

paulaq@wayne.edu

2487168321

Facility Contacts

Nareen Sadik, B.S.

Role: primary

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Other Identifiers

Warrior CARE: CBH

Identifier Type: -

Identifier Source: org_study_id