Clinical trial for THC
Official title Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
ClinicalTrials.gov ID: NCT05999383
What this study is testing
What is Cannabis (Marijuana) via PAX vaporizer?
An investigational method of delivering THC to study its combined effects with tobacco in healthy adults.
Also referred to as Marijuana.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how THC and nicotine move through and act on the body when smoked together.
- Who it's for
- Adults who regularly smoke both cannabis and tobacco.
- What's involved
- Participants will smoke different combinations of cannabis and tobacco in a controlled setting while researchers measure blood levels and other effects.
- Time commitment
- The study lasts a few weeks and involves several visits where participants smoke in a clinic and have blood tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Heart rate \< 105 beats per minute (BPM)\
- Systolic Blood Pressure \ 90\
- Diastolic Blood Pressure \ 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
You likely can't join if
- Heart disease
- Seizures
- Cancer
- Thyroid disease (okay if controlled with medication)
- Diabetes
- Hepatitis B or C or Liver disease
See the full eligibility criteria
- Heart rate \< 105 beats per minute (BPM)\
- Systolic Blood Pressure \ 90\
- Diastolic Blood Pressure \ 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.