search
Back to results

Age-dependent Effects of Smoked and Oral Delta-9-THC (SAGE)

Primary Purpose

Pain, Abuse, Drug, Intoxication; Cannabinoids

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cannabis
Dronabinol
Smoked Placebo
Oral Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Pain, Cannabis, Delta-9-THC, Age, Sex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo Comparator: Placebo

    Experimental: Low strength cannabis

    Experimental: Higher strength cannabis

    Experimental: Low strength oral THC

    Experimental: Higher strength oral THC

    Arm Description

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    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).
    Analgesia as measured using the Cold Pressor Test
    Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
    Impairment
    The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
    Pharmacokinetics of THC and metabolites
    Plasma levels of THC, 11-OH-THC, and THCCOOH

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    May 9, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute on Drug Abuse (NIDA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05865470
    Brief Title
    Age-dependent Effects of Smoked and Oral Delta-9-THC
    Acronym
    SAGE
    Official Title
    Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2027 (Anticipated)
    Study Completion Date
    August 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Abuse, Drug, Intoxication; Cannabinoids
    Keywords
    Pain, Cannabis, Delta-9-THC, Age, Sex

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Model Description
    This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    103 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Comparator: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
    Arm Title
    Experimental: Low strength cannabis
    Arm Type
    Experimental
    Arm Description
    Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
    Arm Title
    Experimental: Higher strength cannabis
    Arm Type
    Experimental
    Arm Description
    Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
    Arm Title
    Experimental: Low strength oral THC
    Arm Type
    Experimental
    Arm Description
    Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
    Arm Title
    Experimental: Higher strength oral THC
    Arm Type
    Experimental
    Arm Description
    Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
    Intervention Type
    Drug
    Intervention Name(s)
    Cannabis
    Other Intervention Name(s)
    Smoked cannabis with THC
    Intervention Description
    smoked cannabis
    Intervention Type
    Drug
    Intervention Name(s)
    Dronabinol
    Other Intervention Name(s)
    Delta-9-THC
    Intervention Description
    Oral delta-9-THC
    Intervention Type
    Drug
    Intervention Name(s)
    Smoked Placebo
    Other Intervention Name(s)
    Placebo smoked cannabis (no THC)
    Intervention Description
    Placebo Cannabis
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Placebo
    Intervention Description
    Oral Placebo
    Primary Outcome Measure Information:
    Title
    Subject-rated drug effects
    Description
    Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).
    Time Frame
    6 hours
    Title
    Analgesia as measured using the Cold Pressor Test
    Description
    Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
    Time Frame
    6 hours
    Title
    Impairment
    Description
    The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
    Time Frame
    6 hours
    Title
    Pharmacokinetics of THC and metabolites
    Description
    Plasma levels of THC, 11-OH-THC, and THCCOOH
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ziva D Cooper, PhD
    Phone
    310-983-3417
    Email
    zcooper@mednet.ucla.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincent Acebo
    Phone
    310-983-3417
    Email
    vacebo@mednet.ucla.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ziva Cooper, PhD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs