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Active, Not Recruiting

NCT Number: NCT04451863

Analgesic and Subjective Effects of Terpenes

The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

The overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or non-pregnant female aged 21-55 years
  • Report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening
  • Not currently seeking treatment for cannabis use
  • Urine test positive for recent cannabis use
  • Have a Body Mass Index from 18.5 - 34kg/m2.
  • Able to perform all study procedures
  • Must be using a contraceptive method (hormonal or barrier methods)

Exclusion criteria

  • Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or mild CUD
  • Report using other illicit drugs in the prior 4 weeks
  • • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
  • Current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes
  • Current pain
  • Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
  • History of an allergic reaction or adverse reaction to cannabis is exclusionary.
  • History of respiratory illness or current respiratory illness
  • History of seizure disorder or current seizure disorder
  • Insensitivity to the cold water stimulus of the Cold Pressor Test
  • Currently enrolled in another research protocol
  • Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)
  • Not using a contraceptive method (hormonal or barrier methods)
  • The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.

Treatment and study plan

Low THC

Drug

Vaporized THC (5 mg)

High THC

Drug

Vaporized THC (15 mg)

Low Myrcene

Drug

Vaporized Myrcene (0.5 mg)

High Myrcene

Drug

Vaporized Myrcene (12.0 mg)

Low Beta-Caryophyllene

Drug

Vaporized Beta-Caryophyllene (0.5 mg)

High Beta-Caryophyllene

Drug

Vaporized Beta-Caryophyllene (7.5 mg)

Placebo

Drug

Vaporized Placebo

Primary outcomes

  1. Analgesia as measured using the Cold Pressor Test

    Time frame: 7 hours

    Pain threshold and pain tolerance assessed using the Cold Pressor Test

  2. Subject-rated drug effects of abuse liability

    Time frame: 7 hours

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

Secondary outcomes

  1. Subject-rated drug effects of intoxication

    Time frame: 7 hours

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

  2. Subjective ratings of pain

    Time frame: 7 hours

    Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
May 15, 2026

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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