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Cannabinoid
CBG + THC for Pain (ASCENT Trial)
Phase 1
Recruiting
Led By Ziva D Cooper, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or non-pregnant and non-lactating females aged 21-55 years
Male or non-pregnant and non-lactating females aged 21-55 years
Must not have
Current pain
History of respiratory illness or current respiratory illness
Timeline
Screening 1 day
Treatment 2 months
Follow Up 7 hours
Summary
This trial will study the effects of the cannabis compound CBG by itself and combined with THC. They will measure pain relief, appetite, and other subjective effects.
Who is the study for?
The ASCENT trial is for men and non-pregnant, non-lactating women aged 21-55 who occasionally use cannabis but aren't seeking treatment for it. Participants must have a BMI of 18.5 - 34kg/m2 and agree to use contraception. Excluded are those with moderate-severe substance disorders (except mild Cannabis Use Disorder), certain mental health conditions, significant illnesses, current pain issues, or respiratory diseases.
What is being tested?
This study examines the effects of cannabigerol (CBG) alone and combined with THC on pain relief and appetite stimulation. It involves different doses: high THC, low CBG, high CBG, low THC, and placebo to compare their impacts in a controlled environment.
What are the potential side effects?
Potential side effects may include typical reactions associated with cannabis such as changes in mood or perception, dry mouth, increased heart rate, red eyes, coordination difficulties or dizziness. The severity can vary based on individual response to THC/CBG.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman not pregnant or breastfeeding, aged 21-55.
Select...
I am a man or a woman not pregnant or breastfeeding, aged 21-55.
Select...
I am not currently breastfeeding.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing pain.
Select...
I have or had a lung or breathing problem.
Timeline
Screening ~ 1 day2 visits
Treatment ~ 2 months9 visits
Follow Up ~ 7 hours
Screening ~ 1 day
Treatment ~ 2 months
Follow Up ~7 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abuse liability
Analgesia
Appetite stimulation
Secondary study objectives
Subjective ratings of intoxication
Subjective ratings of pain
Trial Design
9Treatment groups
Active Control
Placebo Group
Group I: Low strength CBG + High strength THCActive Control2 Interventions
5 mg CBG + 15 mg THC
Group II: High strength THCActive Control1 Intervention
0 mg CBG, 30 mg THC
Group III: High strength CBG + Low strength THCActive Control2 Interventions
15 mg CBG + 5 mg THC
Group IV: High strength CBGActive Control1 Intervention
15 mg CBG, 0 mg THC
Group V: Low strength CBG + Low strength THCActive Control2 Interventions
5 mg CBG + 5 mg THC
Group VI: Low strength THCActive Control1 Intervention
0 mg CBG, 5 mg THC
Group VII: Low strength CBGActive Control1 Intervention
5 mg CBG, 0 mg THC
Group VIII: High strength CBG + High strength THCActive Control2 Interventions
15 mg CBG + 15 mg THC
Group IX: PlaceboPlacebo Group1 Intervention
0 mg CBG, 0 mg THC
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,275 Total Patients Enrolled
9 Trials studying Pain
1,382 Patients Enrolled for Pain
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
609 Total Patients Enrolled
2 Trials studying Pain
32 Patients Enrolled for Pain
Ziva D Cooper, PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Pain
18 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had a lung or breathing problem.You are not using birth control pills, patches, rings, condoms or other forms of contraception.You have a moderate to severe addiction to marijuana or any other drugs except for nicotine, caffeine, or mild marijuana addiction.My doctor agrees cannabis use is safe for me.I haven't taken any medication in the last 14 days or 5 half-lives, except for birth control.I am not currently breastfeeding.You are not currently receiving treatment for cannabis use.I am experiencing pain.I can participate in all required study activities.You need to have a body weight that is considered healthy based on your height.I am a man or a woman not pregnant or breastfeeding, aged 21-55.I am a man or a woman not pregnant or breastfeeding, aged 21-55.You are currently using cannabis and not seeking treatment for it.You have any other mental health condition.Your body weight falls within a certain range based on your height.I use cannabis occasionally, between once every two weeks and three times a week.
Research Study Groups:
This trial has the following groups:- Group 1: Low strength CBG + High strength THC
- Group 2: High strength THC
- Group 3: High strength CBG + Low strength THC
- Group 4: High strength CBG
- Group 5: Low strength CBG + Low strength THC
- Group 6: Low strength THC
- Group 7: Placebo
- Group 8: Low strength CBG
- Group 9: High strength CBG + High strength THC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 2 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pain Patient Testimony for trial: Trial Name: NCT04859296 — Phase 1