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NCT Number: NCT06859723

High Potency Cannabis: Acute and Protracted Effects

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.

Recruiting

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Center for Cannabis and Cannabinoids

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Vincent Acebo

CONTACT

[email protected]

310-983-3417

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator: Placebo

Drug

Placebo

Other names: Cannabis

Low dose THC

Drug

Smoked low dose THC

Other names: Cannabis

High dose THC

Drug

Smoked high dose THC

Other names: Cannabis

Primary outcomes

  1. Subject-rated drug effects of abuse liability

    Time frame: 3 hours

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

  2. Analgesia as measured using the Cold Pressor Test

    Time frame: 3 hours

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

Secondary outcomes

  1. Pharmacokinetics of THC and metabolites

    Time frame: 3 hours

    Peak plasma levels of THC (ng/ml)

  2. Pharmacokinetics of THC and metabolites

    Time frame: 3 hours

    Peak plasma levels of 11-OH-THC (ng/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent Acebo

CONTACT

[email protected]

310-983-3417

Ziva Cooper, PhD

CONTACT

[email protected]

310-206-9942

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • California Department of Cannabis Control (DCC)

Registry information

Acronym: HIGH-CAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 5, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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