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

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Apr 21, 2021

Keywords

ClinConnect Summary

The ASCENT trial is a clinical study looking at how two substances, cannabigerol (CBG) and THC, affect pain relief and appetite stimulation. Researchers want to see how these compounds work on their own and together, particularly for people who occasionally use cannabis. This study is currently recruiting participants aged 21 to 55 who have used cannabis a couple of times a month but are not looking for treatment for cannabis use. To join, participants should have a healthy weight and be using some form of birth control.

If you decide to participate, you'll be involved in a series of study procedures to assess how you respond to CBG and THC. It's important to know that this study excludes individuals with certain health issues, those who are currently in pain, or anyone who is pregnant or breastfeeding. The goal is to better understand how these substances can help with pain and appetite, which could lead to new treatment options in the future.

Gender

ALL

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