Recruiting
Phase 1
Phase 2

Cannabinoids

Sponsor:

Wayne State University

Code:

NCT06381180

Conditions

Post Traumatic Stress Disorder

Cannabis Use

Suicide

Veterans

Marijuana

Eligibility Criteria

Sex: All

Age: 19 - 69

Healthy Volunteers: Not accepted

Interventions

Tetrahydrocannabinol

Cannabidiol

Placebo

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Cannabis Use

Suicide

Veterans

Marijuana

Study ID

NCT06381180

Start date

Sep 22, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 69

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Tetrahydrocannabinol

Plant cannabis that will be smoked

Cannabidiol

Plant cannabidiol that will be smoked

Placebo

Plant will be smoked.

Primary outcome measure

  • Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. [ Time Frame: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits). ]
  • Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment [ Time Frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months ]
  • Assessing Suicidality over time using the C-SSRS assessment. [ Time Frame: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits). ]
  • Assessing Suicidality throughout the study using the SBQ-R assessment. [ Time Frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months ]
  • Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. [ Time Frame: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months ]

Central Contacts and Locations

Central contacts

Leslie Lundahl, PhD

3139931374llundahl@wayne.med.edu

Paula Qefaliaj, B.S.

2486881251paulaq@wayne.edu

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Paula Qefaliaj, B.S.

2486881251paulaq@wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2026-08-07.