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

ConditionsPTSDPost Traumatic Stress DisorderSuicideCannabis Use
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLeslie Lundahl

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

    Plant cannabis that will be smoked.

  • Placebo only

    Drug

    Plant that will be smoked.

  • Delta-9-tetrahydrocannabinol (THC) only

    Drug

    Plant cannabis that will be smoked.

  • THC:CBD 1:1

    Drug

    Plant cannabis that will be smoked.

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: Placebo (PBO) GroupActive 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

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
3

Drug Effects Questionnaire (DEQ)

Subjective ratings of drug effects on from 1-5 on the following scale: "feel", "high", and "like"

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

Visual Analogue Scale of Mood (VAS)

Subjective ratings of mood and drug effects on a 0-100 scale. Higher numbers on the scale reflect stronger experiences of different mood and drug effects. Each item is scored individually. There is no overall score.

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.

Leslie Lundahl

Lead sponsor

Wayne State University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: