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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 belowSelect...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months.
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 moreSecondary outcome measures
Addiction Research Center Inventory (ARCI)
Blood Pressure
Drug Effects Questionnaire (DEQ)
+4 moreTrial 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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cannabinoids, such as THC, interact with the endocannabinoid system by binding to CB1 receptors in the central nervous system. This interaction modulates the release of neurotransmitters and influences the brain's processing of fear and emotional responses.
For PTSD patients, this mechanism is significant because it offers a potential therapeutic approach to reduce symptoms like hypervigilance, anxiety, and intrusive memories by targeting the neurobiological pathways involved in these symptoms.
Find a Location
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
310 Previous Clinical Trials
108,996 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,799 Previous Clinical Trials
2,661,064 Total Patients Enrolled
Christien A Rabinak, PhDPrincipal InvestigatorWayne State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with bipolar disorder, schizophrenia, or any related mental health conditions.You have a history of developmental disorders that affect your ability to communicate and interact with others.You must be right-handed or ambidextrous (able to use both hands equally).You are currently breastfeeding a baby.I am generally healthy with no serious brain health issues affecting my thinking or daily tasks.You have experienced a traumatic event that meets certain criteria and has been identified through a checklist.I have cognitive issues due to a past brain injury.I am not taking any daily medication that severely interacts with dronabinol.You are currently dealing with a serious alcohol or drug addiction.I am between 18 and 60 years old.I feel anxious in small, enclosed spaces.I am allergic or have had bad reactions to cannabis-related substances or ingredients in cannabinoid medications.You have been diagnosed with a severe case of PTSD with a score of 25 or higher on the CAPS-5 test and it has been your main concern for at least a month before the study.You are not able to speak English fluently.You have a mental health condition like depression or anxiety that started before you developed PTSD.I am currently pregnant or planning to become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Dronabinol 7.5 milligram oral capsule
- Group 2: Placebo capsule
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04080427 — Phase 1
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