High Potency Cannabis: Acute and Protracted Effects

NCT06859723 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 24-531693304
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.

Conditions

Abuse Cannabis; Pain; Pharmacokinetics

Keywords

THC; Cannabis

Outcome Measures

Primary Outcomes (2)

• Subject-rated drug effects of abuse liability

  Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)

  3 hours

• Analgesia as measured using the Cold Pressor Test

  Pain threshold assessed using the Cold Pressor Test (percent baseline)

  3 hours

Secondary Outcomes (2)

• Pharmacokinetics of THC and metabolites

  3 hours

• Pharmacokinetics of THC and metabolites

  3 hours

Study Arms (3)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

0 mg THC

Drug: Placebo Comparator: Placebo

Low dose THC

ACTIVE COMPARATOR

50 mg THC

Drug: Low dose THC

High dose THC

ACTIVE COMPARATOR

100 mg THC

Drug: High dose THC

Interventions

Placebo Comparator: Placebo DRUG

Placebo

Also known as: Cannabis

Placebo Comparator: Placebo

Low dose THC DRUG

Smoked low dose THC

Also known as: Cannabis

Low dose THC

High dose THC DRUG

Smoked high dose THC

Also known as: Cannabis

High dose THC

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant and non-lactating females aged 21-55 years
• Report cannabis smoking near daily
• Not currently seeking treatment for their cannabis use
• Have a Body Mass Index from 18.5 - 34kg/m2.
• Able to perform all study procedures
• Must be using a contraceptive (hormonal or barrier methods)

You may not qualify if:

• Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine
• Do not have positive urine toxicology for cannabis use during screening
• 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 predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• California Department of Cannabis Control (DCC): collaborator

Study Sites (1)

UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse; Pain

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ziva Cooper, PhD

CONTACT

310-206-9942; cannabislab@mednet.ucla.edu

Vincent Acebo

CONTACT

310-983-3417; vacebo@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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 5, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)