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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Low strength CBG + High strength THC	High THC	5 mg CBG + 15 mg THC
High strength CBG + Low strength THC	High CBG	15 mg CBG + 5 mg THC
Low strength CBG + High strength THC	Low CBG	5 mg CBG + 15 mg THC
Placebo	Placebo	0 mg CBG, 0 mg THC
Low strength CBG	Low CBG	5 mg CBG, 0 mg THC
High strength CBG	High CBG	15 mg CBG, 0 mg THC
Low strength THC	Low THC	0 mg CBG, 5 mg THC
High strength THC	High THC	0 mg CBG, 30 mg THC
Low strength CBG + Low strength THC	Low CBG	5 mg CBG + 5 mg THC
High strength CBG + Low strength THC	Low THC	15 mg CBG + 5 mg THC
High strength CBG + High strength THC	High CBG	15 mg CBG + 15 mg THC
High strength CBG + High strength THC	High THC	15 mg CBG + 15 mg THC
Low strength CBG + Low strength THC	Low THC	5 mg CBG + 5 mg THC

Primary Outcome Measures

Name	Time	Method
Analgesia	7 hours	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.
Appetite stimulation	7 hours	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.
Abuse liability	7 hours	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.

Secondary Outcome Measures

Name	Time	Method
Subjective ratings of intoxication	7 hours	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.
Subjective ratings of pain	7 hours	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.

Recruitment & Eligibility