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Cannabinoid

THC for Post-Traumatic Stress Disorder

Phase 1
Recruiting
Led By Christien A Rabinak, PhD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between ages 18-60
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 months.
Awards & highlights

Study Summary

This trial is studying how cannabinoids (a type of drug) are related to the processing of fear signals and the experience of emotions and fear. The goal is to see if this could lead to new treatments for anxiety or fear-based disorders.

Who is the study for?
This trial is for adults aged 18-60 with significant PTSD, where it's their primary concern. They must have experienced a traumatic event and be in good general health without serious cognitive impairments. It excludes pregnant or breastfeeding individuals, those with certain mental health conditions, severe substance use issues, allergies to cannabinoids, or MRI contraindications.Check my eligibility
What is being tested?
The study tests the effects of Dronabinol (a synthetic THC) on memory retention related to fear extinction learning in PTSD patients compared to a placebo. The aim is to understand how cannabinoids affect emotional processing and brain activity patterns associated with PTSD treatment.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of cannabinoids like Dronabinol may include dizziness, dry mouth, altered mental state, mood changes, increased heart rate and blood pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain Measures
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)
Expectancy Ratings
+3 more
Secondary outcome measures
Addiction Research Center Inventory (ARCI)
Blood Pressure
Drug Effects Questionnaire (DEQ)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dronabinol 7.5 milligram oral capsuleExperimental Treatment1 Intervention
In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will administer a single oral dose of dronabinol (7.5mg) or placebo (PBO) approximately two hours prior to each weekly exposure session (up to 9 sessions) in a standard prolonged exposure treatment protocol comprising 12 session overall. Half of the participants will receive 7.5mg dronabinol (n=50) and the other half of the participants will receive placebo (n=50).
Group II: Placebo capsulePlacebo Group1 Intervention
In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will administer a single oral dose of dronabinol (7.5mg) or placebo (PBO) approximately two hours prior to each weekly exposure session (up to 9 sessions) in a standard prolonged exposure treatment protocol comprising 12 session overall. Half of the participants will receive 7.5mg dronabinol (n=50) and the other half of the participants will receive placebo (n=50).

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,373 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,175 Total Patients Enrolled
Christien A Rabinak, PhDPrincipal InvestigatorWayne State University

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04080427 — Phase 1
Post-Traumatic Stress Disorder Research Study Groups: Dronabinol 7.5 milligram oral capsule, Placebo capsule
Post-Traumatic Stress Disorder Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT04080427 — Phase 1
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080427 — Phase 1
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04080427 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being included in this medical experiment?

"Affirmative. As noted on clinicaltrials.gov, this medical trial is recruiting patients at the moment. The study was initially advertised on April 15th 2021 and underwent its last update March 10th 2022. 100 participants are needed from one single centre."

Answered by AI

Does this clinical trial cater to individuals over the age of thirty?

"This medical trial is recruiting individuals aged 18 to 60."

Answered by AI

Am I able to join this experiment?

"This clinical trial is willing to accept 100 participants with a documented diagnosis of PTSD, ranging in age from 18-60. To be eligible for the study, individuals must present an exposure to Criterion A stressor as identified by CAPS-5 and LEC-5; demonstrate general medical health and neurological functionality that does not impede task completion; have experienced significant PTSD severity within one month prior to entering the program; and report PTSD as their primary concern."

Answered by AI

What prior research exists about the effects of Dronabinol 7.5 milligram oral capsules?

"Presently, 6 clinical trials for Dronabinol 7.5 milligram oral capsules are in Phase 3; out of a total 38 ongoing studies. Most of these are located within Belmont, Massachusetts but data indicates that there is an expansive network spanning 90 locations researching this medication."

Answered by AI

What are common therapeutic applications of Dronabinol 7.5 milligram oral capsules?

"Dronabinol 7.5 milligram oral capsule is frequently administered to manage weight loss and the inadequate response of conventional therapy, pharmacotherapy, or appetite suppression."

Answered by AI

What are the potential hazards associated with a 7.5 milligram dose of Dronabinol oral capsules?

"The safety of the Dronabinol 7.5 milligram oral capsule was judged to be a 1 on our scale due to this being an early phase trial with limited data supporting efficacy and safety."

Answered by AI

What key outcomes is this trial seeking to determine?

"The primary metric for this trial is the Subjective Units of Distress Scale (SUDS). Secondary outcomes include evaluations with State-Trait Anxiety Inventory (STAI), End of Session Questionnaire (ESQ) and Drug Effects Questionnaire (DEQ). The STAI measures both state anxiety, which includes "I am tense; I am worried" and "I feel calm; I feel secure", as well as trait anxiety such as: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person". Whereas ESQ consists of 5 queries on capsule effects, DEQ surveys"

Answered by AI

Are there open spots for participation in this investigation?

"Data on clinicaltrials.gov verifies that this trial, which was first established on April 15th 2021, is actively recruiting participants. The study's details were most recently updated in March of 2022."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
Eugene Applebaum College of Pharmacy and Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I already know how well cannabinoids work for PTSD. I am trying to find the right one or combination that works without being stoned. Pot edibles that turn into 11 hydroxy DO NOT work, does very little for me like smoking did. But I don't and wont smoke or use dabs or any inhaled delta 9 THC, only edibles and hemp derived cannabinoids.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do you have to go off your current cannabinoids?
PatientReceived 1 prior treatment
~18 spots leftby Dec 2024