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Cannabinoid
Smoked vs Vaped Cannabis on Cardiovascular Risk in Smokers (TRDRP Trial)
N/A
Recruiting
Led By Gideon St. Helen, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-2 of each arm
Awards & highlights
TRDRP Trial Summary
This trial will enroll experienced dual cannabis-tobacco smokers to study the effects of smoking and vaping dry herb cannabis. It will compare THC and toxicant exposure, subjective and cardiovascular effects, and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.
Who is the study for?
This trial is for adults who regularly smoke cannabis and tobacco, with a heart rate under 105 BPM, normal blood pressure, and no severe health issues. They must use cannabis at least three times weekly for the past three months and be willing to vape it if they haven't before. Participants should also smoke five or more cigarettes daily but not have any serious psychiatric conditions or drug/alcohol dependence.Check my eligibility
What is being tested?
The study compares the effects of smoking versus vaping cannabis on THC exposure, toxicant levels, subjective experiences, and cardiovascular risk. It also looks at how these compare to smoking tobacco cigarettes in dual users. The design involves participants trying each method (smoking/vaping) in random order.See study design
What are the potential side effects?
Potential side effects may include changes in heart rate and blood pressure due to THC's cardiovascular effects; respiratory irritation from inhaling smoke; altered mental state including euphoria or paranoia; dry mouth; red eyes; increased appetite.
TRDRP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-2 of each arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-2 of each arm
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the expired carbon monoxide (CO) curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Cardiovascular effects between cannabis products using endothelial dysfunction as a measure
+12 moreSecondary outcome measures
Cardiovascular effects between smoked tobacco and cannabis using endothelial dysfunction as a measure
Cardiovascular effects between smoked tobacco and cannabis using epinephrine as a measure
Cardiovascular effects between smoked tobacco and cannabis using heart rate as a measure
+6 moreTRDRP Trial Design
3Treatment groups
Experimental Treatment
Group I: Smoked Cannabis, Vaped Cannabis, or Tobacco CigaretteExperimental Treatment3 Interventions
Abstinence from any product night before hospital admission
Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
6-hr abstinence and blood draws (PK)
2 hr Free use session w/ video monitoring
Free use of assigned product
12-hr cardiovascular (CV) monitoring
Circadian blood draws
12-hr urine collection
Group II: Remaining productExperimental Treatment3 Interventions
Abstinence from any product night before hospital admission
Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
6-hr abstinence and blood draws (PK)
2 hr Free use session w/ video monitoring
Free use of assigned product
12-hr CV monitoring
Circadian blood draws
12-hr urine collection
Group III: Either of the 2 remaining productsExperimental Treatment3 Interventions
Abstinence from any product night before hospital admission
Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
6-hr abstinence and blood draws (PK)
2 hr Free use session w/ video monitoring
Free use of assigned product
12-hr CV monitoring
Circadian blood draws
12-hr urine collection
Find a Location
Who is running the clinical trial?
Tobacco Related Disease Research ProgramOTHER
25 Previous Clinical Trials
20,600 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,453 Total Patients Enrolled
Gideon St. Helen, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but it seems like you didn't provide any specific information about the medication criterion. Could you please provide more details so I can help you summarize it?Your high blood pressure is not well controlled.You have a thyroid condition, but it's okay if it's being managed with medication.You have mental health conditions.You regularly use smokeless tobacco or pipes. If you are an occasional user, you can still participate if you agree to stop using them during the study.You are currently using medications that contain nicotine.You have a history of fainting.You have other serious illnesses that could be life-threatening, as determined by the study doctor.You have a problem with drugs or alcohol and are dependent on them.You have experienced psychosis or paranoia after using marijuana in the past.You have a high level of dependence on cannabis, scoring 2 or more on a scale that measures how much you rely on it.Your heart beats slower than 105 times per minute.You smoke marijuana at least three times a week using joints or blunts regularly for the past three months.You have used a cannabis vaporizer in the past or are willing to use one during the study.You are an adult with ADHD.You have an enlarged prostate.You are currently undergoing methadone replacement therapy.You are planning to stop smoking or vaping in the next two months.You currently smoke at least 5 cigarettes a day.You have a heart condition.You have been diagnosed with schizophrenia or bipolar disorder in the past or currently.You have other ongoing health conditions that may affect your participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette
- Group 2: Remaining product
- Group 3: Either of the 2 remaining products
Awards:
This trial has 1 awards, including:- 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 this research endeavor recruiting participants presently?
"Yes, the information provided on clinicaltrials.gov shows that this research endeavour is actively enrolling patients. Originally posted 10/30/2020 and most recently updated 8/2/2022, 18 participants are being sought from 2 distinct sites."
Answered by AI
What does this clinical experiment seek to achieve?
"The main outcome being monitored during the first two days of cannabis administration is maximal change in expired carbon monoxide levels. Secondary outcomes include assessing cardiovascular effects by measuring heart rate, comparing toxicant exposure through CO measurements, and examining epinephrine excretion via urine catecholamines."
Answered by AI
How many participants are partaking in this scientific experiment?
"Affirmative. Clinicaltrials.gov data suggests that this medical trial, initially posted on October 30th 2020 is currently recruiting participants. 18 patients will be admitted at 2 study sites for the duration of the research project."
Answered by AI
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