Status:
COMPLETED
THC Crossover Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Tobacco Related Disease Research Program
Conditions:
THC
Cannabis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and ca...
Detailed Description
Experienced dual cannabis-tobacco smokers will participate in a within-subject crossover study with three blocks: smoked cannabis (purchased by participants from a local dispensary), dry herb cannabis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04429568
Start Date
October 30 2020
End Date
June 25 2024
Last Update
July 1 2024
Active Locations (2)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
2
University of California, San Francisco
San Francisco, California, United States, 94143