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THC and CBD: A Controlled Human Study Probing a Harm Reduction Strategy

About

Brief Summary

The purpose of this research is to assess the impact of CBD on the effects of THC.

Primary Purpose
Basic science
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
21 Years
Maximum Age
55 Years

Inclusion Criteria:

  • Male or non-pregnant and non-lactating females aged 21-55 years
  • Report cannabis use 1-7 days per week over the month prior to screening
  • Not currently seeking treatment for their cannabis use
  • History of inhaled cannabis use
  • Have a Body Mass Index from 18.5 - 34 kg/m2
  • Able to perform all study procedures
  • Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

  • Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
  • Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
  • Report using other illicit drugs in the prior 4 weeks
  • Current pain
  • Pregnancy
  • Currently enrolled in another research protocol
  • Not using a contraceptive method (hormonal or barrier methods)
  • Insensitivity to the cold water stimulus of the Cold Pressor Test
  • Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
  • Not able to speak and read English
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Study Stats
Protocol No.
24-5306
Category
Healthy Volunteers
Principal Investigator
Ziva Cooper
Contact
Ziva Cooper
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06859710
For detailed technical eligibility, visit ClinicalTrials.gov.