Safety and Effects on Responses to Stress and Pain of Natural Medical Marijuana Products

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposal aims to systematically examine the safety and pharmacokinetic/pharmacodynamic profile and the physiologic, neuroendocrine and behavioral stress and pain responses to acute single doses and repeated dosing of oral tablet formulation of natural Cannabidiol (CBD) alone and in combination with Tetrahydrocannabinol and matched Placebo (PLA).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Connecticut Pharmaceutical Solutions
• Treatments: Dronabinol; Epidiolex

Criteria

Inclusion Criteria:

1. Able to read and write English;

2. Recreational cannabis use with a minimum history recent use of at least one joint of smoked marijuana;

3. Current chronic pain, as defined by the International Classification of Diseases (ICD)-10, and stabilized for a minimum of 2 weeks on pain medication, (minimum pain ratings of 4 on a 10-point scale) and agree to not change pain medication during course of the study;

4. Body Mass Index (BMI) in the 18-30 range;

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.

2. Any Current Substance Use Disorder, including alcohol and cannabis.

3. Individuals taking any prescription medications or over-the counter medications regularly except chronic pain medications as described above

4. Women with irregular menstrual cycles or those who are nursing, those with dysmenorrhea or amenorrhea, or those who are menopausal, or had premenstrual dysphoric disorder or those on birth control pills;

5. Women who are pregnant as determined by the urine pregnancy test at each assessment period;

6. Inability to give informed consent;

7. Traumatic brain injury or loss of consciousness;

8. Individuals with current or past history of seizure disorders;

9. Patients with chronic pain that is the result of acute illnesses (e.g., cancer, multiple sclerosis) that lead to chronic pain

10. Individuals with hematocrit less than 33 prior to laboratory sessions;

11. Has donated blood within 8 weeks prior to first blood draw of the study