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Oral administration of 30mg ∆9-THC for Cannabis

Phase 1

Waitlist Available

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

Be between the ages of 18 and 55

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-8 hours

Awards & highlights

Study Summary

This trial will study the effects of delta-8-THC, a compound found in hemp, on driving ability, cognitive performance, and biomarkers in the body. Delta-8-THC

Who is the study for?

This trial is for individuals who can safely participate in simulated driving tests and are interested in understanding the effects of different THC compounds. Specific eligibility criteria details were not provided, so participants should inquire with the study organizers for more information.Check my eligibility

What is being tested?

The study is testing how Delta-8-THC compares to Delta-9-THC and a placebo on simulated driving performance. It will also look at their effects on field sobriety tests, cognitive abilities, and cannabinoid levels in the body after vaporization or oral ingestion.See study design

What are the potential side effects?

While specific side effects are not listed, both forms of THC may cause altered perception, dizziness, dry mouth, red eyes, slowed reaction times and could impact short-term memory during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Standard Deviation of Lateral Position (SDLP) in cm

Secondary outcome measures

Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)

Mean Peak Change From Baseline Global Impairment Score as assessed by the DRUID App

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral administration of 60mg ∆8-THCExperimental Treatment1 Intervention

A brownie infused with 60mg ∆8-THC will be eaten by study participants

Group II: Oral administration of 30mg ∆9-THCExperimental Treatment1 Intervention

A brownie infused with 30mg ∆9-THC will be eaten by study participants

Group III: Oral administration of 30mg ∆8-THCExperimental Treatment1 Intervention

A brownie infused with 30mg ∆8-THC will be eaten by study participants

Group IV: Administration of vaporized 60mg ∆8-THCExperimental Treatment1 Intervention

Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")

Group V: Administration of vaporized 30mg ∆9-THCExperimental Treatment1 Intervention

Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")

Group VI: Administration of vaporized 30mg ∆8-THCExperimental Treatment1 Intervention

Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")

Group VII: Oral PlaceboPlacebo Group1 Intervention

A brownie containing no experimental drugs will be eaten by study participants

Group VIII: Administration of vaporized PlaceboPlacebo Group1 Intervention

Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Delta-9-THC

2021

Completed Early Phase 1

~70

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Substance Abuse and Mental Health Services Administration (SAMHSA)FED

30 Previous Clinical Trials

23,263 Total Patients Enrolled

2 Trials studying Cannabis

71 Patients Enrolled for Cannabis

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,452 Total Patients Enrolled

7 Trials studying Cannabis

196 Patients Enrolled for Cannabis

Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University

12 Previous Clinical Trials

540 Total Patients Enrolled

2 Trials studying Cannabis

42 Patients Enrolled for Cannabis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I inquire about the criteria for potential participation in this medical study?

"Eligible candidates for this study must be within the age range of 18 to 55 and have a history of cannabis use. The trial is open to a maximum of 45 participants."

Answered by AI

Are there any available openings for patients to participate in this study?

"According to the information available on clinicaltrials.gov, this particular clinical trial is not currently accepting candidates. The initial posting was made on April 1st, 2024, and the last edit occurred on January 11th, 2024. However, it is worth noting that there are currently 37 other active clinical trials that are actively seeking participants at this time."

Answered by AI

Is the participation in this medical investigation limited to individuals who have reached or surpassed 18 years of age?

"This clinical trial welcomes individuals who are at least 18 years old but not older than 55 years of age."

Answered by AI

Has the Food and Drug Administration granted approval for the use of vaporized 30mg ∆9-THC as a method of administration?

"Based on the information provided, our team at Power assigns a safety rating of 1 to the administration of vaporized 30mg ∆9-THC. This is attributed to it being a Phase 1 trial with limited available data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance

2024. "Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218550.

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