Clinical trial NCT06859723: High Potency Cannabis: Acute and Protracted Effects
Official title: High Potency Cannabis: Acute and Protracted Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Abuse Cannabis
Pain
Pharmacokinetics
Keywords: THC
Cannabis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject-rated drug effects of abuse liability
timeFrame: 3 hours
measure: Analgesia as measured using the Cold Pressor Test
timeFrame: 3 hours
Secondary outcomes:
measure: Pharmacokinetics of THC and metabolites
timeFrame: 3 hours
measure: Pharmacokinetics of THC and metabolites
timeFrame: 3 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Cannabis and Cannabinoids
state: California
Study officials:
References: