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

Primary Purpose

Pain, Appetite Loss, Abuse, Drug

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Low CBG
High CBG
Low THC
High THC
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Analgesia, Pain, Appetite, THC, Cannabigerol, CBG

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Low strength CBG

High strength CBG

Low strength THC

High strength THC

Low strength CBG + Low strength THC

Low strength CBG + High strength THC

High strength CBG + Low strength THC

High strength CBG + High strength THC

Arm Description

0 mg CBG, 0 mg THC

5 mg CBG, 0 mg THC

15 mg CBG, 0 mg THC

0 mg CBG, 5 mg THC

0 mg CBG, 30 mg THC

5 mg CBG + 5 mg THC

5 mg CBG + 15 mg THC

15 mg CBG + 5 mg THC

15 mg CBG + 15 mg THC

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 21, 2021
Last Updated
March 13, 2023
Sponsor
University of California, Los Angeles
Collaborators
Center for Medicinal Cannabis Research
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1. Study Identification

Unique Protocol Identification Number
NCT04859296
Brief Title
AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)
Acronym
ASCENT
Official Title
Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 22, 2024 (Anticipated)
Study Completion Date
December 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Center for Medicinal Cannabis Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Appetite Loss, Abuse, Drug
Keywords
Analgesia, Pain, Appetite, THC, Cannabigerol, CBG

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mg CBG, 0 mg THC
Arm Title
Low strength CBG
Arm Type
Active Comparator
Arm Description
5 mg CBG, 0 mg THC
Arm Title
High strength CBG
Arm Type
Active Comparator
Arm Description
15 mg CBG, 0 mg THC
Arm Title
Low strength THC
Arm Type
Active Comparator
Arm Description
0 mg CBG, 5 mg THC
Arm Title
High strength THC
Arm Type
Active Comparator
Arm Description
0 mg CBG, 30 mg THC
Arm Title
Low strength CBG + Low strength THC
Arm Type
Active Comparator
Arm Description
5 mg CBG + 5 mg THC
Arm Title
Low strength CBG + High strength THC
Arm Type
Active Comparator
Arm Description
5 mg CBG + 15 mg THC
Arm Title
High strength CBG + Low strength THC
Arm Type
Active Comparator
Arm Description
15 mg CBG + 5 mg THC
Arm Title
High strength CBG + High strength THC
Arm Type
Active Comparator
Arm Description
15 mg CBG + 15 mg THC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vaporized placebo
Intervention Type
Drug
Intervention Name(s)
Low CBG
Intervention Description
Vaporized CBG (5 mg)
Intervention Type
Drug
Intervention Name(s)
High CBG
Intervention Description
Vaporized CBG (15 mg)
Intervention Type
Drug
Intervention Name(s)
Low THC
Intervention Description
Vaporized THC (5 mg)
Intervention Type
Drug
Intervention Name(s)
High THC
Intervention Description
Vaporized THC (15 mg)
Primary Outcome Measure Information:
Title
Analgesia
Description
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.
Time Frame
7 hours
Title
Appetite stimulation
Description
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.
Time Frame
7 hours
Title
Abuse liability
Description
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.
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Subjective ratings of intoxication
Description
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.
Time Frame
7 hours
Title
Subjective ratings of pain
Description
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.
Time Frame
7 hours

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Prospective research participants will be healthy, occasional (cannabis use biweekly to ≤ 3 day per week) cannabis-using men and non-pregnant and non-lactating women who will be evaluated for participation according to the following inclusion/exclusion criteria.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziva D Cooper, PhD
Phone
310-206-9942
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziva D Cooper, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziva D Cooper, PhD
Phone
310-794-7497
Email
zcooper@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Vincent Acebo
Phone
310-983-3417
Email
vacebo@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Ziva D Cooper, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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