Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2020-10-30
2024-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette
* 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
Smoked Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
Vaped Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
Tobacco Cigarette
Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
Either of the 2 remaining products
* 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
Smoked Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
Vaped Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
Tobacco Cigarette
Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
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 CV monitoring
* Circadian blood draws
* 12-hr urine collection
Smoked Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
Vaped Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
Tobacco Cigarette
Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
Interventions
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Smoked Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
Vaped Cannabis
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
Tobacco Cigarette
Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
Yes
Sponsors
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Tobacco Related Disease Research Program
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gideon St. Helen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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17-24117
Identifier Type: -
Identifier Source: org_study_id
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