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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
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 moreTrial 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).
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Who is running the clinical trial?
Canopy Growth CorporationIndustry Sponsor
13 Previous Clinical Trials
1,134 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,497 Total Patients Enrolled
Justin Strickland, Ph.D.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
150 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using medications that might interact with the study drug.I have not used cannabis or related products in the last 30 days.I have been on a stable dose of my current medication for at least 30 days.I am a man and will use effective birth control during and 30 days after the study.I have a history of liver issues or my liver tests are higher than normal.I have been diagnosed with a heart condition.I am a woman who can have children and have used birth control for the last 30 days.I am between 18 and 55 years old.I have high blood pressure or my readings are above 150/90 mm Hg.I do not have any health conditions that could affect my participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Oral administration of 2.5 mg THC + 60 mg caffeine
- Group 2: Oral placebo
- Group 3: Oral administration of 2.5 mg THC
- Group 4: Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD
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.
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