CompletedPhase 1

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

United States24 participantsStarted 2022-11-15

Plain-language 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).

Who can participate

Age range21 Years – 68 Years

SexALL

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Inclusion criteria

✓. Able to read and write English;
✓. Recreational cannabis use with a minimum history recent use of at least one joint of smoked marijuana or marijuana edible or other equivalent form;
✓. 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;
✓. Body Mass Index (BMI) in the 18-36 range;

Exclusion criteria

✕. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation.
✕. Any Current moderate/severe Substance Use Disorder, including alcohol and cannabis.
✕. Women who are nursing or have premenstrual dysphoric disorder;
✕. Women who are pregnant as determined by the urine pregnancy test at each assessment period;
✕. Inability to give informed consent;
✕. Traumatic brain injury or loss of consciousness;
✕. Individuals with current or past history of seizure disorders;

What they're measuring

Pain Ratings

Timeframe: Day 1 and 7 provocation during 7-day treatment period

Trial details

NCT IDNCT04226690

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

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