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Cannabinoid
Cannabis for Cannabis
Phase 1
Waitlist Available
Led By Ryan Vandrey
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 5 hours
Awards & highlights
Study Summary
This trial will study how cannabis and nicotine affect each other when used together.
Eligible Conditions
- Cannabis
- Nicotine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of nicotine (mL of smoke/vapor) inhaled
Secondary outcome measures
Behavioral task performance as assessed by the DRUID app
Cannabis Craving as assessed by the Cannabis Craving Questionnaire
Trigger Finger Disorder
+3 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: placebo cannabis with own brand cigarettesExperimental Treatment2 Interventions
Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes
Group II: Placebo cannabis with low nicotine e-cigaretteExperimental Treatment2 Interventions
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Group III: Placebo cannabis with high nicotine e-cigaretteExperimental Treatment2 Interventions
Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Group IV: Active cannabis without nicotineExperimental Treatment1 Intervention
Smoked cannabis containing 10mg THC + No nicotine/tobacco
Group V: Active cannabis with own brand cigarettesExperimental Treatment2 Interventions
Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes
Group VI: Active cannabis with low nicotine e-cigaretteExperimental Treatment2 Interventions
Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL)
Group VII: Active cannabis with high nicotine e-cigaretteExperimental Treatment2 Interventions
Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Medical Cannabis
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,607 Total Patients Enrolled
20 Trials studying Cannabis
1,510 Patients Enrolled for Cannabis
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,627 Total Patients Enrolled
7 Trials studying Cannabis
215 Patients Enrolled for Cannabis
Ryan VandreyPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used cannabis at least 5 times in the past year.You must be between the ages of 18 and 55.You smoke at least five cigarettes per day on average within the last month.You have used an electronic cigarette for at least half of the past month.Not donated blood in the past 30 days.Your body weight is within a healthy range based on your height, with a BMI of 18 to 36 kg/m2.You have used cannabis by inhaling it in the past.Based on a physical examination, a medical history, vital signs, and screening urine and blood tests, be in good general health.The person tested negative for drugs of abuse, except cannabis, via urine sample, and alcohol via breath sample, at the screening visit and upon arrival for each experimental session.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo cannabis with high nicotine e-cigarette
- Group 2: Active cannabis with low nicotine e-cigarette
- Group 3: Active cannabis without nicotine
- Group 4: Active cannabis with own brand cigarettes
- Group 5: Active cannabis with high nicotine e-cigarette
- Group 6: Placebo cannabis with low nicotine e-cigarette
- Group 7: placebo cannabis with own brand cigarettes
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 there currently an opportunity for volunteers to join this research endeavor?
"That is correct. As per the details on clinicaltrials.gov, this medical trial was launched on September 15th 2020 and is currently recruiting patients. The study aims to enrol 60 individuals from 1 site in total."
Answered by AI
What is the magnitude of participants currently enrolled in this experiment?
"Affirmative, the data hosted on clinicaltrials.gov supports that this research project is currently admitting patients. It was initially posted in September 2020 and it was last updated a few weeks ago. This study requires 60 participants to be enrolled from one medical site."
Answered by AI
Is there a way to participate in this clinical experiment?
"This research project is in search of 60 nicotine users aged 18 to 55. The criteria for entry are stringent: physical examination, medical history evaluation, and vital signs; urine and blood tests free from drugs other than cannabis (urine sample) or alcohol (breath sample); BMI between 18 - 36 kg/m2; no donation of blood within the past 30 days."
Answered by AI
To what degree can Cannabis be considered detrimental to human health?
"Cannabis's safety rating from our Power team is a 1 as it is currently undergoing Phase 1 trials and has minimal evidence to prove its effectiveness or safeness."
Answered by AI
Is this research protocol open to those under three-quarters of a century in age?
"Per the criteria for this research, participants must be 18 or older and not exceed 55 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Virginia
District of Columbia
Other
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I want to stop smoking cigarettes.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Johns Hopkins University: < 24 hours
Average response time
- < 1 Day
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