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NCT05865470 | Not yet recruiting | Pain

Age-dependent Effects of Smoked and Oral Delta-9-THC
Sponsor:

University of California, Los Angeles

Information provided by (Responsible Party):

Ziva D. Cooper, PhD

Brief Summary:

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

Condition or disease

Pain

Abuse, Drug

Intoxication; Cannabinoids

Intervention/treatment

Cannabis

Dronabinol

Smoked Placebo

Oral Placebo

Phase

Phase 1

Detailed Description:

The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.}}

Study Type : Interventional
Estimated Enrollment : 103 participants
Masking : Double
Primary Purpose : Basic Science
Official Title : Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
Actual Study Start Date : March 1, 2024
Estimated Primary Completion Date : March 1, 2028
Estimated Study Completion Date : March 1, 2029
Arm Intervention/treatment

Placebo Comparator: Placebo Comparator: Placebo

Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)

Drug: Smoked Placebo

Drug: Oral Placebo

Experimental: Experimental: Low strength cannabis

Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)

Drug: Cannabis

Drug: Oral Placebo

Experimental: Experimental: Higher strength cannabis

Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)

Drug: Cannabis

Drug: Oral Placebo

Experimental: Experimental: Low strength oral THC

Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)

Drug: Dronabinol

Drug: Smoked Placebo

Experimental: Experimental: Higher strength oral THC

Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)

Drug: Dronabinol

Drug: Smoked Placebo
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
  • Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
  • Not currently seeking treatment for their cannabis use
  • No reported clinically significant adverse effects with cannabis use
  • Have a Body Mass Index from 18.5 - 34kg/m2
  • Able to perform all study procedures
  • FEMALES: Currently practicing an effective form of birth control if pre-menopausal
Exclusion Criteria
  • Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
  • Report using other illicit drugs in the prior 4 weeks
  • Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) 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.
  • Current predominant licit use of medical cannabis
  • Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures
  • Current pain
  • Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
  • History of an allergic reaction or adverse reaction to cannabis is exclusionary.
  • Currently enrolled in another research protocol
  • Not using a contraceptive method (hormonal or barrier methods)
  • The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
  • Intolerance to lactose and sesame (ingredients in the oral THC preparation)
  • Insensitivity to the Cold Pressor Test
Age-dependent Effects of Smoked and Oral Delta-9-THC

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Age-dependent Effects of Smoked and Oral Delta-9-THC

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