Analgesic and Subjective Effects of Terpenes

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 1

Conditions: Abuse, Drug; Pain

Treatments: Drug: Placebo; Drug: High Beta-Caryophyllene; Drug: High THC; Drug: High Myrcene; Drug: Low Beta-Caryophyllene; Drug: Low Myrcene; Drug: Low THC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04451863

R01AT010762-04 (U.S. NIH Grant/Contract)

19-001519

Details and patient eligibility

About

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

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 15 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0 mg THC, 0 mg myrcene, 0 mg BCP

Treatment:

Drug: Placebo

Low strength THC

Active Comparator group

Description:

5 mg THC, 0 mg myrcene, 0 mg BCP

Treatment:

Drug: Low THC

Higher strength THC

Active Comparator group

Description:

15 mg THC, 0 mg myrcene, 0 mg BCP

Treatment:

Drug: High THC

Low strength myrcene

Active Comparator group

Description:

0 mg THC, 0.5 mg myrcene, 0 mg BCP

Treatment:

Drug: Low Myrcene

High strength myrcene

Active Comparator group

Description:

0 mg THC, 12.0 mg myrcene, 0 mg BCP

Treatment:

Drug: High Myrcene

Low strength BCP

Active Comparator group

Description:

0 mg THC, 0 mg myrcene, 0.5 mg BCP

Treatment:

Drug: Low Beta-Caryophyllene

High strength BCP

Active Comparator group

Description:

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Treatment:

Drug: High THC

Drug: High Beta-Caryophyllene

Low THC + Low myrcene

Active Comparator group

Description:

5 mg THC, 0.5 mg myrcene, 0 mg BCP

Treatment:

Drug: Low THC

Drug: Low Myrcene

Low THC + High myrcene

Active Comparator group

Description:

5 mg THC, 12.0 mg myrcene, 0 mg BCP

Treatment:

Drug: Low THC

Drug: High Myrcene

High THC + Low myrcerne

Active Comparator group

Description:

15 mg THC, 0.5 mg myrcene, 0 mg BCP

Treatment:

Drug: Low Myrcene

Drug: High THC

High THC + High myrcene

Active Comparator group

Description:

15 mg THC, 12.0 mg myrcene, 0 mg BCP

Treatment:

Drug: High Myrcene

Drug: High THC

Low THC + Low BCP

Active Comparator group

Description:

5 mg THC, 0 mg myrcene, 0.5 mg BCP

Treatment:

Drug: Low THC

Drug: Low Beta-Caryophyllene

Low THC + High BCP

Active Comparator group

Description:

5 mg THC, 0 mg myrcene, 7.5 mg BCP

Treatment:

Drug: Low THC

Drug: High Beta-Caryophyllene

High THC + Low BCP

Active Comparator group

Description:

15 mg THC, 0 mg myrcene, 0.5 mg BCP

Treatment:

Drug: Low Beta-Caryophyllene

Drug: High THC

High THC + High BCP

Active Comparator group

Description:

15 mg THC, 0 mg myrcene, 7.5 mg BCP

Treatment:

Drug: High THC

Drug: High Beta-Caryophyllene