NCT04385082

Brief Summary

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 pain

Timeline
14mo left

Started Jul 2021

Longer than P75 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2021Jul 2027

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

May 7, 2020

Last Update Submit

March 17, 2026

Conditions

PainAbuse, Drug

Keywords

PainCannabisTHC

Outcome Measures

Primary Outcomes (3)

  • Subject-rated drug effects

    Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).

    5 hours

  • Analgesia as measured using the Cold Pressor Test

    Peak and average pain threshold and tolerance assessed using the Cold Pressor Test

    5 hours

  • Pharmacokinetics of THC and metabolites

    Plasma levels of THC, 11-OH-THC, and THCCOOH

    5 hours

Secondary Outcomes (1)

  • Drug reinforcement using the cannabis self-administration task

    5 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Smoked Cannabis (\~0% THC)

Drug: Placebo Cannabis

Low strength cannabis

EXPERIMENTAL

Smoked Cannabis (\~4% THC)

Drug: Active Cannabis

Higher strength cannabis

EXPERIMENTAL

Smoked Cannabis (\~10% THC)

Drug: Active Cannabis

Interventions

Active CannabisDRUG

Smoked cannabis with THC

Higher strength cannabisLow strength cannabis
Placebo CannabisDRUG

Placebo smoked cannabis (no THC)

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or non-pregnant female aged 21-55 years
  • Report use of cannabis an average of 1-7 days per week
  • Not currently seeking treatment for their cannabis use
  • Urine test positive for recent cannabis use for heavy users
  • No reported adverse effects with cannabis smoking in light users
  • Have a Body Mass Index from 18.5 - 34kg/m2.
  • Able to perform all study procedures
  • FEMALES: Currently practicing a non-hormonal effective form of birth control
  • FEMALES: Must be regularly cycling

You may not qualify if:

  • Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
  • Report using other illicit drugs in the prior 4 weeks
  • History or current evidence of severe psychiatric illness or medical condition 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 use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
  • Current pain
  • Insensitivity to the cold water stimulus of the Cold Pressor Test
  • FEMALES: using a hormonal contraceptive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

PainSubstance-Related DisordersMarijuana Abuse

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Ziva Cooper, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziva Cooper, PhD

CONTACT

310-206-9942zcooper@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417vacebo@mednet.ucla.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

July 8, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)