THC Crossover Study (TRDRP)
THC, Cannabis, Cannabis Smoking
About this trial
This is an interventional basic science trial for THC focused on measuring vape, cannabis, tobacco cigarette, thc, marijuana, smoking
Eligibility Criteria
Inclusion Criteria:
- Healthy on the basis of medical history and limited physical examination, as described below:
Heart rate < 105 beats per minute (BPM); Systolic Blood Pressure < 160 and > 90*; Diastolic Blood Pressure < 100 and > 50*
*Considered out of range if both machine and manual readings are above/below these thresholds.
- Current regular user of cannabis who smokes cannabis as joint or blunt at least 3 times a week for past 3 months
- History of cannabis vaporizer use or willingness to use the vaporizer in the study
- Current tobacco cigarette use who smokes ≥ 5 cigarettes per day
- Saliva cotinine ≥ 50 ng/ml
- Test positive for D-9-tetrahydrocannabinol (THC) at screening and self-report of cannabis use
Exclusion Criteria:
- Unstable medical conditions:
Heart disease; Uncontrolled hypertension; Thyroid disease (okay if controlled with medication); Diabetes; Hepatitis B or C or Liver disease; Glaucoma; Prostatic hypertrophy
- Psychiatric conditions:
Current or past schizophrenia, and/or current or past bipolar disorder; Adult onset attention deficit hyperactivity disorder (ADHD); Participants with current or past depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion; History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician's approval
- Concurrent regular use of smokeless tobacco or pipes [occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study]
- Medications:
Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs).; Concurrent use of nicotine-containing medications; Psychiatric medications: current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) and current evaluation by the study physician that the participant is otherwise healthy, stable, and able to participate.
- Other/Misc. Chronic Health Conditions:
Oral thrush; Fainting; Untreated thyroid disease; Other "life threatening illnesses" as per study physician's discretion
- Pregnancy:
Pregnancy (self-reported and urine pregnancy test); Breastfeeding (determined by self-report)
- Drug/Alcohol Dependence:
Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program; Positive toxicology test at the screening visit (THC & prescribed medications okay); Methadone replacement therapy
- Concurrent participation in another clinical trial
- Inability to communicate in English
- History of marijuana-induced psychosis or paranoia after smoking marijuana
- Scoring a 2 or higher on the Severity of Dependence Scale for cannabis use
- Planning to quit smoking or vaping within the next 60 days
Sites / Locations
- Zuckerberg San Francisco General HospitalRecruiting
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette
Either of the 2 remaining products
Remaining product
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
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
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