In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (7.5mg) or placebo (PBO) approximately two hours prior to fMRI scanning and task performance in 40 patients with PTSD, 40 trauma-exposed controls without PTSD (TEC), and 40 non-exposed healthy controls (HC).
Within each of the three groups half of the participants will receive dronabinol and the other half will received placebo to create the following 6 groups:
PTSD-dronabinol (20)
PTSD-placebo (20)
TEC-dronabinol (20)
TEC-placebo (20)
HC-dronabinol (20)
HC-placebo (20)

Post-Traumatic Stress Disorder

Dronabinol (7.5mg) is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive dronabinol.

Dronabinol

Placebo is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive placebo.

Placebo

Eugene Applebaum College of Pharmacy and Health Sciences

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

functional magnetic resonance imaging (fMRI) BOLD percent signal change within region of interests [amygdala; ventromedial prefrontal cortex; hippocampus].

Skin conductance response (SCR): change in SCR [peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation].

To assess the expected likelihood that an aversive cue (e.g. noise burst or shock) will occur or not based on while slide was shown, participants will repeatedly 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; 2 = certain that the aversive cue will not be presented; 3 = uncertain whether the aversive cue will be presented].

Subjective Units of Distress (SUDS): used to measure fear ratings/"subjective" anxiety on a scale from 0-100; taken at three time points throughout the tasks: before the task begins, in the middle of the task, and at the end of the task.

(1) Visual Analog Scales (VAS); and (2) Drug Effects Questionnaire (DEQ); (3) Addiction Research Center Inventory (ARCI); (4) Spielberger Trait/State Anxiety Inventory (STAI). At completion of the extinction session, participants will complete the End of Session Questionnaire (ESQ). These measures are collected immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards, unless otherwise specified (e.g., DEQ will also be collected at 90, 150min, 8 hours and 24 hours, ESQ only at 240 min).

Heart rate and blood pressure will be collected at regular intervals throughout Visit 3 [immediately before capsule ingestion (Time 0), and 30, 60, 120, 180, and 240 minutes afterwards].

Christine Rabinak, PhD

Assistant Professor

Wayne State University

Epidemiologic Data of Some Synthetic Cannibinoids Toxicity in Patients Presenting at Assiut University Hospital, Psychiatric Hospital of Ministry of Health)

Proportion of Acute and Chronic Abusers of Synthetic Cannibinoids Among Cases of Illicit Drugs Abuser in Studied Sites

Epidemiological data (age, sex, residence, occupation, route of abuse, the cause of abuse and smoking) (2) Symptoms and signs (seizures, psychosis, hallucinations) (3) Injuries and their relation to violence (type of wound, type of instrument, number of injuries, external or internal injuries and assailant or victim).

causes of abuse synthetic cannibinoids

Egypt

Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals

Evaluation of Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals (Clinical and Experimental Study)

the magnitude and spread of this new drug of abuse

MKMAbdelrahim

assistant lecturer

Assiut University

These were participants who consented but were excluded prior to neuroimaging and randomization because they did not meet study criteria.

Non-Randomized Participants

This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure. There was insufficient data to analyze the dronabinol and placebo groups separately due to an inability to meet statistical power considerations. Thus, for the results, the placebo and dronabinol subjects were combined into one group.

Placebo/Dronabinol

Total

Sex/Gender, Customized

Region of Enrollment

Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.

All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.

All Participants

Physiological Changes in Response to Cue-induced Craving.

Reports of side effects leading to discontinuation of treatment were examined in all participants.

This arm represents the participants who, following neuroimaging procedure and randomization, were given either placebo or Dronabinol

Tolerability of Treatment

All Screened Participants

All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.

Placebo 10mg QID

Dronabinol 10mg QID

Screening

Baseline Functional MRI

Randomization

Dr. Marina Goldman, Principle Study Investigator

37 consented subjects were determined to be ineligible for randomization.

This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure.

Marijuana Dependence

10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week

BRENDA therapy

4 capsules daily for 2 weeks followed by a 1 week taper

black/cannabis

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals

Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

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