Analgesic and Subjective Effects of Terpenes

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

Detailed Description
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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.

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

Conditions
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Pain, Abuse, Drug

Intervention / Treatment
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* Drug: Low THC
* Drug: High THC
* Drug: Low Myrcene
* Drug: High Myrcene
* Drug: Low Beta-Caryophyllene
* Drug: High Beta-Caryophyllene
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0 mg THC, 0 mg myrcene, 0 mg BCP | Drug: Placebo<br>* Vaporized Placebo<br>|
| Active Comparator: Low strength THC<br>5 mg THC, 0 mg myrcene, 0 mg BCP | Drug: Low THC<br>* Vaporized THC (5 mg)<br>|
| Active Comparator: Higher strength THC<br>15 mg THC, 0 mg myrcene, 0 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>|
| Active Comparator: Low strength myrcene<br>0 mg THC, 0.5 mg myrcene, 0 mg BCP | Drug: Low Myrcene<br>* Vaporized Myrcene (0.5 mg)<br>|
| Active Comparator: High strength myrcene<br>0 mg THC, 12.0 mg myrcene, 0 mg BCP | Drug: High Myrcene<br>* Vaporized Myrcene (12.0 mg)<br>|
| Active Comparator: Low strength BCP<br>0 mg THC, 0 mg myrcene, 0.5 mg BCP | Drug: Low Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (0.5 mg)<br>|
| Active Comparator: High strength BCP<br>15 mg THC, 0 mg myrcene, 7.5 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>Drug: High Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (7.5 mg)<br>|
| Active Comparator: Low THC + Low myrcene<br>5 mg THC, 0.5 mg myrcene, 0 mg BCP | Drug: Low THC<br>* Vaporized THC (5 mg)<br>Drug: Low Myrcene<br>* Vaporized Myrcene (0.5 mg)<br>|
| Active Comparator: Low THC + High myrcene<br>5 mg THC, 12.0 mg myrcene, 0 mg BCP | Drug: Low THC<br>* Vaporized THC (5 mg)<br>Drug: High Myrcene<br>* Vaporized Myrcene (12.0 mg)<br>|
| Active Comparator: High THC + Low myrcerne<br>15 mg THC, 0.5 mg myrcene, 0 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>Drug: Low Myrcene<br>* Vaporized Myrcene (0.5 mg)<br>|
| Active Comparator: High THC + High myrcene<br>15 mg THC, 12.0 mg myrcene, 0 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>Drug: High Myrcene<br>* Vaporized Myrcene (12.0 mg)<br>|
| Active Comparator: Low THC + Low BCP<br>5 mg THC, 0 mg myrcene, 0.5 mg BCP | Drug: Low THC<br>* Vaporized THC (5 mg)<br>Drug: Low Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (0.5 mg)<br>|
| Active Comparator: Low THC + High BCP<br>5 mg THC, 0 mg myrcene, 7.5 mg BCP | Drug: Low THC<br>* Vaporized THC (5 mg)<br>Drug: High Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (7.5 mg)<br>|
| Active Comparator: High THC + Low BCP<br>15 mg THC, 0 mg myrcene, 0.5 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>Drug: Low Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (0.5 mg)<br>|
| Active Comparator: High THC + High BCP<br>15 mg THC, 0 mg myrcene, 7.5 mg BCP | Drug: High THC<br>* Vaporized THC (15 mg)<br>Drug: High Beta-Caryophyllene<br>* Vaporized Beta-Caryophyllene (7.5 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia as measured using the Cold Pressor Test | Pain threshold and pain tolerance assessed using the Cold Pressor Test | 7 hours | 
| Subject-rated drug effects of abuse liability | Subject ratings of Good Drug Effect as measured using a visual analog scale (1-100 mm) | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-rated drug effects of intoxication | Subject ratings of High as measured using a visual analog scale (1-100 mm) | 7 hours | 
| Subjective ratings of pain | Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test | 7 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis, Analgesia, Pain, THC, Terpenes