50 mother-infant pairs with self-reported maternal chronic cannabis use during pregnancy

60 mother-infant pairs with no self-reported maternal cannabis use during pregnancy

Maternal urine at 28-36 weeks gestation; maternal plasma and urine at delivery; neonate urine, meconium, cord blood and cord segment shortly after birth; maternal urine at 2 weeks postpartum; maternal urine at 1 year postpartum

Cannabis Use Disorder

PREG1

Drug Use

Fetal Exposure During Pregnancy

Neurodevelopmental Abnormality

This study plans to enroll pregnant women.

no intervention, this is a purely observational study

University of Colorado Hospital

Denver Health Medical Center

The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity

Four subscales on the IBQ-R will be combined to form a negative affectivity scale including scales of Sadness, Distress to Limitations, Fear, and Falling Reactivity/Rate of Recovery from Distress.

A completely de-identified dataset will be created and may be shared upon PI-agreement ad development of data sharing agreements.

University of Colorado, Denver

National Institute on Drug Abuse (NIDA)

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

⋄Heavy Marijuana Users : 60-80 years old; Marijuana use initiated in adolescence with marijuana use of no more than 1-2 x/month after 30 years of age; Used marijuana more than 20 times/month for at least 1 year during this period. Cigarette smoking (tobacco) and alcohol will be allowed in both groups, which will be matched on number of smokers and nicotine dependence, measured according to the Fagerstrőm Test for Nicotine Dependence. Light alcohol use will also be allowed in and matched across both groups (< 14 drinks/week for men; < 7 drinks/week for women; may not meet DSM-IV criteria for alcohol dependence).

⋄No marijuana use, may smoke cigarettes, fewer than 7 drinks/week (women) or 14 drinks/week (men). 60-80 years old.

Study Focuses on Brain Morphology and Cognition in Older Subjects

UCLA Semel/Resnick Neuropsychiatric Institute

Cannabis Effects on Brain Morphology in Aging

Effects of Heavy Adolescent Cannabis Use on Brain Morphology in Aging

Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with high resolution MRI to assess subtle MTL morphology.

Investigators will identify sources of structural differences in aging, heavy cannabis users compared to non-users with HARDI-DTI to investigate white matter structure.

Investigators will use neuropsychological testing to assess episodic encoding and delayed memory performance. Investigators will also investigate whether any long-term cognitive deficits relate to gray matter or white matter deficits.

Alison Burggren

Assistant Researcher

University of California, Los Angeles

clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks

risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks

Clozapine

Risperidone

Total

Sex: Female, Male

Region of Enrollment

Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use were gathered weekly using the Timeline Follow-back (TLFB) method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as "Improved," "Unchanged," or "Worse" by a pair of expert judges. Raters were instructed to rate the graph "Improved" or "Worsened" if it appeared to be >20% better or worse and to rate it "Unchanged" if there was little or no change (less than ~20%).

Number of Participants Demonstrating Improvement in Substance Use

Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on psychiatric symptoms were gathered using Brief Psychiatric Rating Scale (BPRS; weekly), Clinical Global Impressions Scale (CGIS; weekly) and Schedule for the Assessment of Negative Symptoms (SANS; bi-weekly). At the end of the study, graphs were plotted showing severity of symptoms and rated as "Improved," "Unchanged," or "Worse" by a pair of expert judges. Raters were instructed to rate the graph "Improved" or "Worsened" if it appeared to be >20% better or worse and to rate it "Unchanged" if there was little or no change (less than ~20%).

Number of Participants Demonstrating Improvement in Psychiatric Symptoms Using the BPRS, CGIS, and SANS at 24 Weeks

Overall Study

Alan I. Green, M.D.

Cannabis-Related Disorder

Substance-Related Disorders

Schizophrenia

Psychotic Disorders

clozapine--tabs, 450mg. max, daily, 24 weeks

clozapine

risperidone--tabs, 6mg max, daily, 24 weeks

white/mbangi

The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity

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

Cannabis Effects on Brain Morphology in Aging

First Episode Schizophrenia and Cannabis-Related Disorder Study

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