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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
Timeline
Screening 1 day
Treatment 2 months
Follow Up 7 hours
Awards & highlights
ASCENT Trial 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.Check my eligibility
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.See study design
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.
ASCENT Trial 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.
ASCENT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abuse liability
Analgesia
Appetite stimulation
Secondary outcome measures
Subjective ratings of intoxication
Subjective ratings of pain
ASCENT 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 CBG + Low strength THCActive Control2 Interventions
15 mg CBG + 5 mg THC
Group III: Low strength CBG + Low strength THCActive Control2 Interventions
5 mg CBG + 5 mg THC
Group IV: High strength CBGActive Control1 Intervention
15 mg CBG, 0 mg THC
Group V: High strength THCActive Control1 Intervention
0 mg CBG, 30 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
1,532 Previous Clinical Trials
10,265,248 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 CBG + Low strength THC
- Group 3: Low strength CBG + Low strength THC
- Group 4: High strength CBG
- Group 5: High 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation accept applicants who are younger than eighty years old?
"Participants must fall between the ages of 21 and 55 in order to meet this study's enrollment criteria."
Answered by AI
Could you provide information about any prior experiments that have tested Low strength CBG + Low strength THC?
"At the present moment, there are 38 medical studies investigating Low strength CBG + Low strength THC. Of those trials, 6 have reached Phase 3. Most of these research projects occur in Belmont, Massachusetts; however, 90 different clinical sites across the nation are running similar experiments."
Answered by AI
What effects can people expect from a blend of low-potency CBG and THC?
"A combination of low-dose CBG and THC can ameliorate conditions like inadequate response to conventional therapy, pharmacotherapy, anorexia, and weight loss."
Answered by AI
Is this investigation still open to enrolling participants?
"At the current moment, clinicaltrials.gov does not list this trial as recruiting any more participants. Initially posted on June 20th 2022 and last updated May 13th 2022, there are a plethora of other studies actively looking for volunteers - 734 to be exact!"
Answered by AI
To what extent could the combination of low strength CBG and THC be considered hazardous to patients?
"In consideration of the limited data supporting both safety and efficacy, we at Power have assigned Low strength CBG + Low strength THC a score of 1."
Answered by AI
To what extent is enrollment in this trial restricted?
"Requirements for participation in this research project require that patients demonstrate symptoms of pain and are between 21 and 55 years old. Currently, around 20 individuals have been accepted to the study."
Answered by AI
How many patients will be enrolled in this investigation?
"Presently, this trial is closed to new participants. Originally posted on June 20th of 2022 and last updated May 13th, there are currently numerous other medical studies searching for volunteers with pain (696) and those interested in Low strength CBG + low THC treatments (38)."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0
What questions have other patients asked about this trial?
How long is the intake?
PatientReceived no prior treatments
Why did patients apply to this trial?
Currently no questions. Substance use disorder. I'm tired of chronic pain and self medicating to feel better.
PatientReceived 2+ prior treatments
CURRENTLY ON LYRICA 100mg, FOR NERVE DAMAGE AND HYDROCODONE .525mg. I'm using pain medication and cannabis and still have issues with my arthritis pain.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- University of California, Los Angeles: < 48 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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