Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study

NCT03008005 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1R61MH111935-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

Conditions

PostTraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Brain Measures

  Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests \[amygdala; ventromedial prefrontal cortex; hippocampus\] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.

  Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day

• Expectancy Ratings

  To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 \[1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)\]. Counts of "yes", "no", and "I don't know" are collected on the first (early) trial of the CS and the last (late) trial of the CS.

  Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.

Study Arms (3)

Placebo Oral Capsule

PLACEBO COMPARATOR

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Placebo Oral Capsule

Dronabinol Cap 5 milligrams (MG)

EXPERIMENTAL

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Dronabinol Cap 5 milligrams (MG)

Dronabinol Cap 10 milligrams (MG)

EXPERIMENTAL

In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD. One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).

Drug: Dronabinol Cap 10 milligrams (MG)

Interventions

Placebo Oral Capsule DRUG

Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.

Also known as: sugar pill

Placebo Oral Capsule

Dronabinol Cap 5 milligrams (MG) DRUG

Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.

Also known as: Marinol

Dronabinol Cap 5 milligrams (MG)

Dronabinol Cap 10 milligrams (MG) DRUG

Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.

Also known as: Marinol

Dronabinol Cap 10 milligrams (MG)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to give informed consent
• Right-handed
• Age between 18-50 years old,
• Physically and neurologically healthy \[confirmed by a comprehensive medical history\]
• Current PTSD diagnosis

You may not qualify if:

• clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol
• any current (or within past 2 months) medical condition requiring medication that would interact with dronabinol or interfere with the study protocol
• risk of harm to self or others that requires immediate intervention
• presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
• lack of fluency in English
• positive drug screen or alcohol breathalyzer
• unwilling/unable to sign informed consent document
• currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women)
• under 18 or over 50 years of age
• traumatic brain injury (as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement (i.e., whiplash) without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)
• inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner
• left-handed;
• presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
• anticipation of a required drug test in the 4 weeks following the study.
• current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Eugene Applebaum College of Pharmacy and Health Sciences

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Sugars; Dronabinol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Christine Rabinak, Principal Investigator
• Organization: Wayne State University

rabinak@wayne.edu

(313) 577-9875

Study Officials

• Christine A. Rabinak, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: January 2, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 22, 2025
• Results First Posted: September 8, 2022

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)