Status:
RECRUITING
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Conditions:
THC
Cannabis
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. ...
Detailed Description
This is a single-center, within-subject (crossover), randomized, double-blinded clinical pharmacology study of over 8 study visits (days). Participants will be non-treatment-seeking, healthy frequent ...
Eligibility Criteria
Inclusion
- 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.
- Body Mass Index (BMI) ≤ 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues)
- Current regular user of cannabis who smokes or vapes cannabis or THC extracts at least three days a week for the past 3 months or more
- Test positive for D-9-tetrahydrocannabinol (THC) at screening and self-report of cannabis use
- Current user of inhaled forms of tobacco/nicotine (cigarette, cigars, e-cigarettes) who use the product daily for the past 3 months or more
- Saliva cotinine ≥ 30 ng/mL
Exclusion
- Unstable medical conditions:
- Heart disease
- Seizures
- Cancer
- Thyroid disease (okay if controlled with medication)
- Diabetes
- Hepatitis B or C or Liver disease
- Glaucoma
- Kidney disease or urinary retention
- An ulcer in the past year
- Active use of an inhaler for asthma or Chronic Obstructive Pulmonary Disease (COPD)
- Hypertension if uncontrolled (meaning participant has a diagnosis, but they are not taking medication/under treatment (e.g., diet or exercise plan)
- Drug/Alcohol Dependence
- Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program
- Positive toxicology test at the screening visit (THC \& prescribed medications okay)
- Opioid replacement therapy (including methadone, buprenorphine, or other)
- Psychiatric conditions
- Current or past schizophrenia, and/or current or past bipolar disorder
- Major depression, current or within the past year
- Major personality disorder
- Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI \[study physician\] and considered for inclusion
- History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's \[study physician's\] approval
- 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 PI that the participant is otherwise healthy, stable, and able to participate
- Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases)
- Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy)
- Traumatic brain injury
- Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
- 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
- Any stimulant medications (ex. Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment
- Other/Misc. Chronic Health Problems
- Oral thrush
- Fainting
- Other "life threatening illnesses" as per study physician's discretion
- Pregnancy
- Pregnancy (self-reported and urine pregnancy test)
- Breastfeeding (determined by self-report)
- Concurrent participation in another clinical trial
- Inability to communicate in English
- History of marijuana-induced psychosis or paranoia after smoking marijuana
- Scoring a 7 or higher on the Severity of Dependence Scale (SDS) for cannabis use
- Planning to quit smoking or vaping within the next 60 days
- Planning to quit cannabis use within the next 60 days
- Uncomfortable with getting blood drawn
- Willingness to abstain from tobacco smoking and all combustible products for 13 hours before admission
- Willingness to abstain from smoking/ingestion of cannabis 13 hours before
- Willingness to abstain from nicotine products 13 hours before each admission
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05999383
Start Date
July 1 2025
End Date
February 1 2028
Last Update
January 7 2026
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110