Healthy Clinical Trial
Official title:
Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.
Purpose: To examine the neurological effects of cannabis on stress reactivity and inhibition in healthy adults using recreational cannabis. This is a phase I/pilot healthy subjects trial. Primary Hypotheses: 1. The intervention will be feasible to implement 2. Cannabis oil will attenuate stress, measured via biological and self-report data, including salivary molecules, functional Magnetic Resonance Imaging, and standardized psychosocial assessments. Justification: Current cannabis research focuses on medical uses for cannabis, clinical populations and/or non-commercially available products. There remains limited experimental research on the effects of commercial products in non-clinical regular users of cannabis. Further, most drug use research excludes polysubstance users. Given the high number of people using cannabis to cope with stress, biological evidence is needed to determine the validity of this claim. Stress is known to negatively impact daily functioning and has been linked to poorer mental and physical health outcomes. The effects of cannabinoids on cognitive functioning also have implications for daily functioning. Objectives: Determine a causal link between commercially available cannabinoid products and mechanisms involved with stress response in polysubstance users, specifically weekly cannabis users with heavy drinking (males: minimum 5 drinks, females: minimum 4 drinks on at least one occasional per month for the past 12 months). Examine the short-term effects of cannabinoids on sleep quality in this population. Study Design: The study is a Phase I non-therapeutic pilot trial and will utilize a double-blind, placebo-controlled, within-subjects design. The acute effects of the investigational products (IPs) will be examined. Each participant will undergo an initial phone screen and 5 sessions, with sessions 2-4 involving drug administration. There will be three investigational product arms for the drug administration sessions: cannabis oil with a high ratio of THC to CBD, cannabis oil with a high ratio of CBD to THC, and placebo. Each participant will be exposed to all three arms, one per drug administration session. The order of arm will be randomized. Each drug administration session will be a minimum of10 days apart to ensure a sufficient washout period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |