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RecruitingNCT06859723HIGH-CAPUpdated Sep 4, 2026

High Potency Cannabis: Acute and Protracted Effects

A Phase 1 interventional study of Placebo Comparator: Placebo and Low dose THC in Abuse Cannabis, Pain and Pharmacokinetics, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Abuse Cannabis
  • Pain
  • Pharmacokinetics

Keywords

  • THC
  • Cannabis
03

In context

Marijuana Abuse

517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    Placebo Comparator: Placebo

    0 mg THC

    Drug: Placebo Comparator: Placebo

  • Active comparator
    Low dose THC

    50 mg THC

    Drug: Low dose THC

  • Active comparator
    High dose THC

    100 mg THC

    Drug: High dose THC

Interventions

  • DrugPlacebo Comparator: Placebo

    Placebo

    Also known as: Cannabis

  • DrugLow dose THC

    Smoked low dose THC

    Also known as: Cannabis

  • DrugHigh dose THC

    Smoked high dose THC

    Also known as: Cannabis

06

What researchers measure

Primary outcomes

  1. Subject-rated drug effects of abuse liability

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

    Time frame: 3 hours

  2. Analgesia as measured using the Cold Pressor Test

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

    Time frame: 3 hours

Secondary outcomes

  1. Pharmacokinetics of THC and metabolites

    Peak plasma levels of THC (ng/ml)

    Time frame: 3 hours

  2. Pharmacokinetics of THC and metabolites

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

    Time frame: 3 hours

07

Study locations

1 of 1 sites recruiting
  • UCLA Center for Cannabis and Cannabinoids
    Los Angeles, California 90095, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06859723
Lead sponsor
University of California, Los Angeles
Collaborators
California Department of Cannabis Control (DCC)
Responsible party
Ziva D. Cooper, PhD (Professor, University of California, Los Angeles) — Principal investigator
First posted
Mar 5, 2025
Start date
Jul 3, 2025
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Sep 4, 2026

Study contacts

Ziva Cooper, PhD
Contact
cannabislab@mednet.ucla.edu
310-206-9942
Vincent Acebo
Contact
vacebo@mednet.ucla.edu
310-983-3417

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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