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New treatment option for Cannabis Use
Official title The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
ClinicalTrials.gov ID: NCT05602649
What this study is testing
What is Cannabis?
Cannabis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cannabis use.
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
- This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 55. Healthy volunteers may be eligible.
You may be able to join if
- Have provided written informed consent.
- Be between the ages of 21 and 55.
- Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
- Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy...
You likely can't join if
- Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription...
- History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
- Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as...
- History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the...
- Evidence of current psychiatric condition (based on MINI for DSM-5).
- Been in treatment previously for cannabis use disorder.
See the full eligibility criteria
- Have provided written informed consent.
- Be between the ages of 21 and 55.
- Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
- Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.
- Have prior experience using THC-dominant cannabis.
- Have a body mass index (BMI) in the range of 16 to 38 kg/m2.
- Have not donated blood in the past 30 days.
- Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.
- History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
- Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as...
- History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.
- Evidence of current psychiatric condition (based on MINI for DSM-5).
- Been in treatment previously for cannabis use disorder.
- Receiving of any drug as part of a research study within the past 30 days.
- History of epilepsy or other serious medical condition.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.