Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery

NCT06222268 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB-23-05-5773
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.

Conditions

PTSD; Post Traumatic Stress Disorder

Keywords

Veterans

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  Clinician Administered PTSD Scale for DSM-5 (CAPS-5 Score), anxiety, mood, suicidality, disability. The CAPS-5 is a clinician interview that determines the presence and severity of PTSD consistent with the Diagnostic \& Statistical Manual 5 (DSM-5) and allows for assessing changes in symptom severity over time. PTSD diagnosis is based on meeting the DSM-5 symptom cluster criteria (minimum threshold of symptoms with a score ≥ 2) with a qualifying criterion A index trauma. The CAPS-5 Total Severity Score is calculated by summing the total score for each of the four symptom categories to assess past-month PTSD symptoms on a specific traumatic event: intrusion (Category B), Avoidance (Category C), Mood and Cognition (Category D), and Hyperarousal (Category E). CAPS-5 Total Severity scores range from 0-80, where higher scores indicate worse PTSD severity.

  Through study completion, an average of 12 months

Secondary Outcomes (17)

• Brain measures

  Pre and post treatment-Through study completion, an average of 12 months

• Heart rate

  through study completion, an average of 12 months

• Blood pressure

  through study completion, an average of 12 months

• Skin conductance response

  through study completion, an average of 12 months

• Drug Effects Questionnaire (DEQ)

  through study completion, an average of 12 months

Study Arms (4)

Placebo (PBO) only

PLACEBO COMPARATOR

In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.

Drug: Placebo only

Cannabidiol (CBD) only

EXPERIMENTAL

In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.

Drug: Cannabidiol (CBD) only

Delta-9-tetrahydrocannabinol (THC) only

EXPERIMENTAL

In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.

Drug: Delta-9-tetrahydrocannabinol (THC) only

THC:CBD 1:1

EXPERIMENTAL

In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.

Drug: THC:CBD 1:1

Interventions

Cannabidiol (CBD) only DRUG

Cannabis consisting of 2.5mg CBD and 0mg Delta-9-tetrahydrocannabinol (THC) is administered via smoking.

Also known as: Cannabis

Cannabidiol (CBD) only

Placebo only DRUG

Placebo is administered via smoking in the same way as active drugs. Placebo cannabis material obtained through National Institute of Drug Abuse (NIDA) contains 0mg THC and 0mg CBD

Also known as: Sugar Pill

Placebo (PBO) only

Delta-9-tetrahydrocannabinol (THC) only DRUG

Cannabis containing 2.5mg THC and 0mg CBD is administered via smoking.

Also known as: Cannabis

Delta-9-tetrahydrocannabinol (THC) only

THC:CBD 1:1 DRUG

Cannabis containing 2.5mg of THC and 2.5mg of CBD is administered via smoking.

Also known as: Cannabis

THC:CBD 1:1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to consent to the study
• Agree to comply with requirements and procedures
• Veteran who has served in a branch of the US armed forces
• Between ages 18-60
• Report using cannabis within the past three years but not more than twice in the past month
• Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5); trauma does not have to be related to combat or military service
• Significant PTSD severity as indicated by CAPS-5 diagnosis and/or score \>= 25 of at least one month prior to study entry, PTSD is patient's primary concern
• not currently receiving any psychotherapy for PTSD

You may not qualify if:

• Pregnant, lactating or are a heterosexually active, pre-menopausal woman who is NOT using medically approved birth control (e.g., oral or depot contraception, contraceptive implant, IUD, condom/foam, sterilization, tubal ligation)
• Current or past diagnosis of any bipolar or related disorder or schizophrenia spectrum and other psychotic disorder as determined by the SCID-5 or previous diagnosis by a licensed psychologist or psychiatrist
• Determined to be at high risk for suicide requiring immediate intervention based on the C-SSRS and/or clinician judgment
• Meet criteria for substance use disorder other than Cannabis Use Disorder or Alcohol (Mild or Moderate) or Nicotine Use Disorder, determined by the SCID-5
• Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to smoking cannabis
• Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with cannabis
• Currently receiving psychotherapy for PTSD or previously received exposure-based PTSD treatment
• Current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, systemic, pulmonary, pulmonary fibrosis, or other forms of restrictive lung disease, immunocompromising, or neurological disease
• Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD
• Cognitive exhibit impairment
• Lack of fluency in English
• Insufficient memory of the index traumatic event
• Pervasive development disorder history
• Seeking or currently undergoing treatment for Cannabis Use Disorder.
• Traumatic brain injury (TBI) with current cognitive impairment related to TBI

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cannabidiol; Single Person; nabiximols; Sugars; Dronabinol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Carbohydrates

Central Study Contacts

Paula Qefaliaj

CONTACT

(313) 993-1374; paulaq@wayne.edu

Leslie Lundahl, PhD

CONTACT

(313) 993-1374

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: January 24, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)