High Potency Cannabis: Acute and Protracted Effects

NCT ID: NCT06859723

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2028-07-01

Brief Summary

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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.

Detailed Description

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This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with \~50 mg and \~100 mg THC compared to placebo (\~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.

Conditions

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Abuse Cannabis Pain Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Comparator: Placebo

0 mg THC

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Placebo

Intervention Type DRUG

Placebo

Low dose THC

50 mg THC

Group Type ACTIVE_COMPARATOR

Low dose THC

Intervention Type DRUG

Smoked low dose THC

High dose THC

100 mg THC

Group Type ACTIVE_COMPARATOR

High dose THC

Intervention Type DRUG

Smoked high dose THC

Interventions

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Placebo Comparator: Placebo

Placebo

Intervention Type DRUG

Low dose THC

Smoked low dose THC

Intervention Type DRUG

High dose THC

Smoked high dose THC

Intervention Type DRUG

Other Intervention Names

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Cannabis Cannabis Cannabis

Eligibility Criteria

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Inclusion Criteria

* • 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)

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California Department of Cannabis Control (DCC)

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Ziva D. Cooper, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ziva Cooper, PhD

Role: CONTACT

310-206-9942

Vincent Acebo

Role: CONTACT

310-983-3417

Facility Contacts

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Vincent Acebo

Role: primary

310-983-3417

Other Identifiers

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93304

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-5316

Identifier Type: -

Identifier Source: org_study_id

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