Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of using marijuana and tobacco together. Researchers want to understand how these substances interact when smoked or vaped at the same time. The study will involve participants who regularly use both marijuana and tobacco products. By examining how THC (the active ingredient in marijuana) and nicotine (found in tobacco) affect the body when used together, the researchers hope to gather important information about the health impacts of combining these substances.

To be eligible for the trial, participants need to be between 18 and 65 years old and must be regular users of both marijuana and tobacco, using them daily for at least the past three months. They also need to meet certain health criteria, such as having a normal heart rate and blood pressure. Participants will be asked to visit the study site several times, where they will receive different combinations of marijuana and tobacco to see how their bodies respond. It’s important to note that participants will need to avoid using any tobacco or cannabis products for several hours before each visit. This study is still in the planning phase and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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.
• • 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 Criteria:
• * 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