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

ConditionsPTSDPost Traumatic Stress Disorder
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWayne State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabidiol (CBD) only

    Drug

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

  • 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

  • Delta-9-tetrahydrocannabinol (THC) only

    Drug

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

  • THC:CBD 1:1

    Drug

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

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: Placebo (PBO) onlyPlacebo comparator 1 intervention
Group B: Cannabidiol (CBD) onlyExperimental treatment 1 intervention
Group C: Delta-9-tetrahydrocannabinol (THC) onlyExperimental treatment 1 intervention
Group D: THC:CBD 1:1Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Through study completion, an average of 12 months

Secondary outcomes

1

Brain measures

Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen level dependent (BOLD) changes in regions of interest (amygdala, ventromedial prefrontal cortex, hippocampus) during tasks.

Time frame
Pre and post treatment-Through study completion, an average of 12 months
2

Heart rate

Heart rate is taken prior to the start of prolonged exposure therapy sessions, in the middle of the session before exposure and at the end of the session.

Time frame
through study completion, an average of 12 months
3

Blood pressure

systolic and diastolic will be assessed before, during and after prolonged exposure therapy session. Specifically this measure is taken during drug sessions to measure the changes in physiological arousal during drug consumption.

Time frame
through study completion, an average of 12 months
4

Skin conductance response

Skin conductance is a measure of physiological arousal, it can be used to measure periods of heightened emotional responses to stimuli, here it is used to confirm fear conditioning.

Time frame
through study completion, an average of 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

Source ClinicalTrials.gov

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