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

Pain Clinical Trial

— SAGE  

Official title:

Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05865470
• Other study ID #: 22-001292
• Secondary ID: R01DA057252
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2024
• Est. completion date: August 1, 2028

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Ziva D Cooper, PhD
• Phone: 310-983-3417
• Email: zcooper[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 103
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abuse, Drug
• Pain
• Substance-Related Disorders

Intervention

Drug:
• Cannabis
smoked cannabis
• Dronabinol
Oral delta-9-THC
• Smoked Placebo
Placebo Cannabis
• Oral Placebo
Oral Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-rated drug effects	Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).	6 hours
Primary	Analgesia as measured using the Cold Pressor Test	Peak and average pain threshold and tolerance assessed using the Cold Pressor Test	6 hours
Primary	Impairment	The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score	6 hours
Primary	Pharmacokinetics of THC and metabolites	Plasma levels of THC, 11-OH-THC, and THCCOOH	6 hours