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

University of California, Los Angeles (UCLA)

Status and phase: Enrolling; Phase 1

Conditions: Abuse, Drug; Appetite Loss; Pain

Treatments: Drug: Low THC; Drug: Placebo; Drug: High THC; Drug: Low CBG; Drug: High CBG

Study type: Interventional

Funder types: Other

Identifiers

NCT04859296

21-000208

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0 mg CBG, 0 mg THC

Treatment:

Drug: Placebo

Low strength CBG

Active Comparator group

Description:

5 mg CBG, 0 mg THC

Treatment:

Drug: Low CBG

High strength CBG

Active Comparator group

Description:

15 mg CBG, 0 mg THC

Treatment:

Drug: High CBG

Low strength THC

Active Comparator group

Description:

0 mg CBG, 5 mg THC

Treatment:

Drug: Low THC

High strength THC

Active Comparator group

Description:

0 mg CBG, 30 mg THC

Treatment:

Drug: High THC

Low strength CBG + Low strength THC

Active Comparator group

Description:

5 mg CBG + 5 mg THC

Treatment:

Drug: Low CBG

Drug: Low THC

Low strength CBG + High strength THC

Active Comparator group

Description:

5 mg CBG + 15 mg THC

Treatment:

Drug: Low CBG

Drug: High THC

High strength CBG + Low strength THC

Active Comparator group

Description:

15 mg CBG + 5 mg THC

Treatment:

Drug: High CBG

Drug: Low THC

High strength CBG + High strength THC

Active Comparator group

Description:

15 mg CBG + 15 mg THC

Treatment:

Drug: High CBG

Drug: High THC