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Stimulant

Cannabinoid-Caffeine Combo for Energy and Focus Effects

Phase < 1
Recruiting
Led By Justin Strickland, Ph.D.
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 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
Awards & highlights

Study Summary

This trialwill assess how THC, CBD and caffeine together affect energy, alertness and focus. Results may show how CBD can reduce the negative side effects of caffeine.

Who is the study for?
This trial is for adults aged 18-55 with a BMI of 18-35 who have previously used THC and caffeine. They must be willing to follow study rules, provide informed consent, and if on medication, it should be stable for at least 30 days prior. Pregnant women or those planning pregnancy soon are excluded.Check my eligibility
What is being tested?
The study tests how different combinations of oral CBD, THC, caffeine, and placebo affect energy levels and cognitive performance in participants. It's a double-blind study where neither the researchers nor participants know who receives which combination until after the trial.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cannabis such as altered sensory perception and mood changes or to caffeine like jitteriness or increased heart rate. The specific side effects from their combination are what this trial aims to discover.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®)
Driving Performance on the Driving Simulator
Secondary outcome measures
Change in subjective feelings of alertness
Change in subjective feelings of anxiety
Change in subjective feelings of energy
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBDExperimental Treatment3 Interventions
Acute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120).
Group II: Oral administration of 2.5 mg THC + 60 mg caffeineExperimental Treatment2 Interventions
Acute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120).
Group III: Oral administration of 2.5 mg THCExperimental Treatment1 Intervention
Acute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120).
Group IV: Oral placeboPlacebo Group1 Intervention
Acute administration of oral placebo three times in study session (Time 0, 60, and 120).

Find a Location

Who is running the clinical trial?

Canopy Growth CorporationIndustry Sponsor
13 Previous Clinical Trials
1,134 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,145 Total Patients Enrolled
Justin Strickland, Ph.D.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Caffeine (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05478863 — Phase < 1
Cannabinoid Pharmacology Research Study Groups: Oral placebo, Oral administration of 2.5 mg THC, Oral administration of 2.5 mg THC + 60 mg caffeine, Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD
Cannabinoid Pharmacology Clinical Trial 2023: Caffeine Highlights & Side Effects. Trial Name: NCT05478863 — Phase < 1
Caffeine (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478863 — 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 clinical investigation accept participants aged 75 and above?

"This medical trial is enlisting subjects in the 18 to 55 year old age bracket."

Answered by AI

Are individuals still eligible to join this investigation?

"Per the latest update hosted on clinicaltrials.gov, this therapeutic trial is accepting applications from potential candidates. This study was first publicized to the public on January 20th of 2021 and has had a recent amendment as of January 31st 2021."

Answered by AI

To what extent has this research attracted participants?

"Affirmative. Clinicaltrials.gov has information indicating that this trial is presently open for recruitment, with the first listing dated January 20th 2023 and last updated on January 31st 2023. It aims to enrol a total of twenty participants from one medical centre."

Answered by AI

What are the criteria for eligibility in this research project?

"This clinical trial seeks 20 participants, aged 18-55 who display cannabinoid behavioral pharmacology. Additionally, candidates must have a BMI between 18 and 35 Kg/m^2, provide informed consent, be familiar with cannabis and caffeine products; furthermore they should not change their medication regimen for 30 days prior to the study. Lastly all participants are expected to comply with the restrictions and procedures associated with this experiment."

Answered by AI

What objectives are researchers trying to achieve with this experiment?

"This medical trial will measure Driving Performance on the Driving Simulator over a timespan of 0, 30, 90, 150, 170, 240, 360 and 480 minutes post drug administration. Secondary objectives include gauging Change in subjective feelings of anxiety (via STAI-S), energy levels (through VAMS) and alertness (by means of VAMS)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Pharmacodynamics of Cannabinoid-Caffeine Combinations
2023. "The Pharmacodynamics of Cannabinoid-Caffeine Combinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05478863.
~0 spots leftby May 2024
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