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Terpene
THC + Alpha-pinene Inhalation Effects
Phase 1
Recruiting
Led By Ryan Vandrey, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90)
Be between the ages of 18 and 55
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights
Study Summary
This trial will study how well vaporized alpha-pinene and THC work when inhaled.
Who is the study for?
Participants aged 18-55, with a BMI of 18-36 kg/m2, in good health as determined by physical exams and tests. Women must not be pregnant/nursing and test negative for pregnancy. All must test negative for drugs (except cannabis) and alcohol, have no allergies to THC or pinene, demonstrate cognitive competency, and not use certain medications that could affect the study.Check my eligibility
What is being tested?
The trial is studying the effects of vaporized alpha-pinene and THC when inhaled. It will look at how these substances are processed by the body (pharmacokinetics) and their impact on behavior and bodily functions (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include typical reactions to THC such as altered senses/perception, changes in mood, impaired body movement, difficulty with thinking/memory tasks, an increased heart rate or potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I passed a cognitive test with a good score.
Select...
I am between 18 and 55 years old.
Select...
I am not allergic to THC or pinene.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)
Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
Working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT)
Trial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaporized low alpha-pineneExperimental Treatment1 Intervention
0.5mg of vaporized alpha-pinene
Group II: Vaporized low THC and low alpha-pineneExperimental Treatment2 Interventions
0.5mg of vaporized alpha-pinene with 10mg vaporized THC
Group III: Vaporized low THC and high alpha-pineneExperimental Treatment2 Interventions
5mg of vaporized alpha-pinene with 10mg vaporized THC
Group IV: Vaporized low THC aloneExperimental Treatment1 Intervention
10mg of vaporized pure THC
Group V: Vaporized high alpha-pineneExperimental Treatment1 Intervention
5mg of vaporized alpha-pinene
Group VI: Vaporized high THC and low alpha-pineneExperimental Treatment2 Interventions
0.5mg of vaporized alpha-pinene with 25mg vaporized THC
Group VII: Vaporized high THC and high alpha-pineneExperimental Treatment2 Interventions
5mg of vaporized alpha-pinene with 25mg vaporized THC
Group VIII: Vaporized high THC aloneExperimental Treatment1 Intervention
25mg of vaporized pure THC
Group IX: PlaceboPlacebo Group1 Intervention
Placebo (5mL distilled water)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THC
2017
Completed Phase 1
~330
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,133 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,377 Total Patients Enrolled
Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University
12 Previous Clinical Trials
553 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical condition (like seizures) or mental health condition (like psychosis) that could make it risky for you to participate in the study.I have anemia or I donated blood in the last 30 days.Your body weight is within a healthy range based on your height.I passed a cognitive test with a good score.You have been using cannabis more than twice a week for the past three months.I have a history of serious heart rhythm problems or spasms in my blood vessels.You have sought medical help in the past for dealing with negative effects after using cannabis.I haven't taken any prescription drugs that could affect the study in the last 14 days, except for birth control.I have not taken Marinol® in the last month.I haven't taken any OTC drugs, supplements, or vitamins in the last 14 days that could affect the study.I am between 18 and 55 years old.I am not allergic to THC or pinene.My overall health is good, as confirmed by recent medical exams and tests.You have not used any recreational drugs (except for nicotine, alcohol, or caffeine) in the past three months before being evaluated for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vaporized low THC and low alpha-pinene
- Group 2: Vaporized low THC alone
- Group 3: Vaporized high alpha-pinene
- Group 4: Vaporized high THC and high alpha-pinene
- Group 5: Placebo
- Group 6: Vaporized high THC alone
- Group 7: Vaporized low alpha-pinene
- Group 8: Vaporized high THC and low alpha-pinene
- Group 9: Vaporized low THC and high alpha-pinene
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative currently recruiting participants?
"Clinicaltrials.gov attests that this medical experiment, first uploaded on November 5th 2020, is actively gathering participants. The details of the trial were later amended on June 6th 2022."
Answered by AI
Who satisfies the criteria to be eligible for this clinical experiment?
"Eligibility criteria for the trial necessitates that possible participants possess THC and be between 18-55 years old. 32 individuals have been identified as necessary to complete this study."
Answered by AI
Has the FDA sanctioned THC for therapeutic purposes?
"The limited clinical data surrounding THC's safety and efficacy led to our team at Power assigning it a score of 1 on the scale from 1-3."
Answered by AI
What precedent has been set for the use of THC in past clinical experiments?
"One clinical trial involving THC is underway, however it has yet to reach Phase 3. The primary study site for this treatment is in Baltimore, Maryland; though there are other locations running trials as well."
Answered by AI
How many participants have volunteered to take part in this clinical experiment?
"Affirmative. According to information released on clinicaltrials.gov, this trial is still open for enrollment and was first uploaded November 5th 2020 with its most recent update occuring June 6th 2022. There are a total of 32 participants being sought from one particular medical site."
Answered by AI
Are individuals aged 25 or more eligible to enroll in this trial?
"To be eligible for this medical trial, one must meet the age criteria of being over 18 and under 55 years old."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Other
Florida
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Is my travel paid for if I can go to Boston?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
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