AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)

Study Overview
=================
Brief Summary
-----------------
This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

Detailed Description
-----------------
The overall aim of this double-blind, placebo-controlled, within-subject study in healthy, occasional cannabis smokers is to ascertain the dose-dependent analgesic and appetite-stimulating effects of ecologically relevant doses of cannabigerol (CBG) alone and in combination with a sub-analgesic / sub-appetite stimulating, minimally psychoactive dose of THC and an analgesic, appetite-stimulating, but intoxicating dose of THC.

Official Title
-----------------
Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol

Conditions
-----------------
Pain, Appetite Loss, Abuse, Drug

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Low CBG
* Drug: High CBG
* Drug: Low THC
* Drug: High THC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant and non-lactating females aged 21-55 years • Report occasional use of cannabis (cannabis use between ≥ biweekly and ≤ 3 days per week) over the month prior to screening 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) Females must not be lactating Exclusion Criteria: Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, or mild CUD Any other Axis I disorder • Current use of any medications within 14 days or 5 half-lives of administration (whichever is longer) except for hormonal contraceptives in females. If a medication is taken once a participant is enrolled, sessions will be suspended for 14 days or 5 half-lives after administration (whichever is longer) If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are 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 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 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 are exclusionary, as determined by the evaluating physician

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 CBG, 0 mg THC | Drug: Placebo<br>* Vaporized placebo<br>|
| Active Comparator: Low strength CBG<br>5 mg CBG, 0 mg THC | Drug: Low CBG<br>* Vaporized CBG (5 mg)<br>|
| Active Comparator: High strength CBG<br>15 mg CBG, 0 mg THC | Drug: High CBG<br>* Vaporized CBG (15 mg)<br>|
| Active Comparator: Low strength THC<br>0 mg CBG, 5 mg THC | Drug: Low THC<br>* Vaporized THC (5 mg)<br>|
| Active Comparator: High strength THC<br>0 mg CBG, 30 mg THC | Drug: High THC<br>* Vaporized THC (15 mg)<br>|
| Active Comparator: Low strength CBG + Low strength THC<br>5 mg CBG + 5 mg THC | Drug: Low CBG<br>* Vaporized CBG (5 mg)<br>Drug: Low THC<br>* Vaporized THC (5 mg)<br>|
| Active Comparator: Low strength CBG + High strength THC<br>5 mg CBG + 15 mg THC | Drug: Low CBG<br>* Vaporized CBG (5 mg)<br>Drug: High THC<br>* Vaporized THC (15 mg)<br>|
| Active Comparator: High strength CBG + Low strength THC<br>15 mg CBG + 5 mg THC | Drug: High CBG<br>* Vaporized CBG (15 mg)<br>Drug: Low THC<br>* Vaporized THC (5 mg)<br>|
| Active Comparator: High strength CBG + High strength THC<br>15 mg CBG + 15 mg THC | Drug: High CBG<br>* Vaporized CBG (15 mg)<br>Drug: High THC<br>* Vaporized THC (15 mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia | Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold. | 7 hours | 
| Appetite stimulation | Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation. | 7 hours | 
| Abuse liability | Subject ratings of Good Drug Effect as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability. | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ratings of intoxication | Subject ratings of High as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of intoxication. | 7 hours | 
| Subjective ratings of pain | Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test. Scale is from 0 (Not painful / bothersome at all) to 10 (The most painful / bothersome feeling imaginable), higher ratings indicate greater painfulness and bothersomeness. | 7 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THC, Analgesia, Pain, Appetite, Cannabigerol, CBG