What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for PTSD, particularly those involving cannabinoids like THC and CBD, can have several side effects. These may include sedation, dizziness, disorientation, and psychoactive effects such as altered mood and perception. Other common treatments for PTSD, such as selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT), can also have side effects. SSRIs may cause nausea, insomnia, and sexual dysfunction, while CBT generally has fewer side effects but may initially increase anxiety as patients confront traumatic memories.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by regulating serotonin levels in the brain. While cannabinoids like THC and CBD are being studied for their potential to modulate fear processing and emotional regulation through the endocannabinoid system, they have not yet received FDA approval for PTSD treatment. Current research is exploring their efficacy and safety, but more evidence is needed before they can be considered a standard treatment option.

What other types of research exist?

Promising alternatives to cannabinoids for PTSD treatment include: <ol> <li>Selective Serotonin Reuptake Inhibitors (SSRIs): Commonly prescribed for PTSD, SSRIs like sertraline and paroxetine are FDA-approved and help regulate mood and anxiety.</li> <li>Prazosin: An alpha-1 adrenergic receptor antagonist, prazosin is used to treat PTSD-related nightmares and sleep disturbances.</li> <li>MDMA-Assisted Psychotherapy: Emerging research shows that MDMA, in combination with psychotherapy, can significantly reduce PTSD symptoms.</li> <li>Ketamine: Known for its rapid antidepressant effects, ketamine is being studied for its potential to alleviate PTSD symptoms.</li> <li>Stellate Ganglion Block (SGB): A procedure that involves injecting a local anesthetic into the stellate ganglion, which may help reduce PTSD symptoms by modulating the sympathetic nervous system.</li> <li>Transcranial Magnetic Stimulation (TMS): A non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, showing promise in treating PTSD.</li> </ol>

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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

Must not have

Traumatic brain injury (TBI) with current cognitive impairment related to TBI

Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with dronabinol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 months.

Summary

This trial is testing whether cannabinoids, like THC, can help people with PTSD manage their fear and anxiety. PTSD patients often struggle with severe symptoms that are hard to treat. The study will see if these compounds can change how the brain processes fear signals, potentially leading to better treatments. Cannabinoids have shown potential in reducing PTSD symptoms such as anxiety, sleep disturbances, and hyperarousal in preliminary studies.

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.

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.

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

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive issues due to a past brain injury.

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I am not taking any daily medication that severely interacts with dronabinol.

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I feel anxious in small, enclosed spaces.

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I am currently pregnant or planning to become pregnant.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Measures

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)

Expectancy Ratings

+3 more

Secondary study objectives

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

0 / 5Eligibility criteria met

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.