Provided with up to 1.8 g of marijuana with more tetrahydrocannabinol than cannabidiol

Provided with up to 1.8 g of marijuana per day of marijuana with more cannabidiol than tetrahydrocannabinol

Provided with up to 1.8 g per day of marijuana with an approximately equal amount of tetrahydrocannabinol and cannabidiol

Provided with 1.8 per day of marijuana with very low levels of tetrahydrocannabinol and cannabidiol

Posttraumatic Stress Disorder

Three weeks of smoking marijuana containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

High THC Marijuana

Three weeks of smoking marijuana containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

High CBD Marijuana

Three weeks of smoking marijuana containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day.

High THC/high CBD marijuana

Three weeks of smoking marijuana with low levels of THC and CBD, with smoking limited to no more than 1.8 per day.

Placebo marijuana

Scottsdale Research Institute

Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Posttraumatic Stress Disorder (PTSD)

Clinician-Administered PTSD Scale, a measure of PTSD symptom severity

Multidisciplinary Association for Psychedelic Studies

Investigational product will be administered via vaporization up to 2 grams per day as needed.

Product will be administered via vaporization up to 2 grams per day as needed.

High THC/Low CBD Cannabis

High THC/High CBD Cannabis

Low THC/Low CBD Cannabis

University of British Columbia

Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder

Placebo-Controlled, Triple-Blind, Crossover Study of the Safety and Efficacy of Three Different Potencies of Vaporized Cannabis in 42 Participants With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Tilray

In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.

In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning

In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.
Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo.

Placebo

In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning
Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol.

Dronabinol

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Mean BOLD hippocampal signal during extinction learning and retention task in brain responsebetween the placebo (PBO) and the dronabinol (THC) group. Target areas are analyzed from fMRI scans. The scans were completed on days 1, 2, 3, and 9. Participants were randomized to the PBO and THC condition and received either placebo or dronabinol on day 2, 2 hours prior to extinction learning. Data from days 1, 2, 3, & 9 was combined and a single value was averaged for each group.

BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)

Overall Study

Dr. K. Luan Phan

Healthy Participants

Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol.

Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo.

Cannabinoid Control of Fear Extinction Neural Circuits in Humans

K. Luan Phan, MD

Professor

University of Illinois at Chicago

National Institute of Mental Health (NIMH)

National Institutes of Health (NIH)

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.

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.

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

Patients diagnosed with schizophrenia both on medication and off medication

Healthy volunteers with a first degree relative with alcoholism

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

Healthy volunteers with no current or past major medical or psychiatric history

Patients diagnosed with Post Traumatic Stress Disorder

Patients diagnosed with Opioid Use Disorder

At the screening visit, genomic DNA will be extracted from whole blood, assigned a code, and stored for analysis of group differences in the frequency of CB1R alleles and to examine the relationship between allelic variation at the CB1R locus and [11-C] OMAR binding. In addition, other genes or markers that may be related to brain function or to behavior may be studied.

Schizophrenia

Cannabis Dependence

Prodromal for Psychotic Illness

Family History of Alcoholism

Healthy Control

Opioid-use Disorder

Post Traumatic Stress Disorder

The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

[11-C]OMAR

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Characterization of CB1 Receptors Using [11-C]OMAR

This study will utilize the radioligand [11C]OMAR and High Resolution Research Tomography (HRRT) Positron Emission Tomography (PET) to measure brain CB1 receptor availability in all study populations.
Those in the cannabis dependent population of the study will have PET scanning on three occasions: once within four weeks of screening while smoking as usual, once 48-hours later after remaining abstinent, and once four weeks later after remaining abstinent. The change in receptor density at each time point will be evaluated.
Those in the other populations will have PET scanning done on one occasion within four weeks of screening.

post-traumatic stress disorder/cannabis

Study of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder

Cannabinoid Control of Fear Extinction Neural Circuits in Humans

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

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

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