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New treatment option for Cannabis Intoxication
Official title Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
ClinicalTrials.gov ID: NCT06293040
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 intoxication.
Also referred to as THC.
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 human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order.
- 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- Have provided written informed consent
- Be at least 21 years of age
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- 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...
- Have not donated blood in the prior 30 days
You likely can't join if
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
- History of or current evidence of significant medical condition that would put the participant at risk
- Evidence of current psychiatric condition (MINI for DSM-V)
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- CIWA-Ar score \> 9
- Use of cannabis, on average, more than 3 days/week over past 3 months
See the full eligibility criteria
- Have provided written informed consent
- Be at least 21 years of age
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- 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 each study visit
- Have not donated blood in the prior 30 days
- Report at least 1 day of binge drinking in the past 3 months (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
- Report at least 1 use of cannabis in the past 3 years
- Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
- Report at least 1 lifetime instance of simultaneous alcohol and cannabis use
- Current concomitant prescription medication use that may interact with the investigational study drug, including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow...
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
- History of or current evidence of significant medical condition that would put the participant at risk
- Evidence of current psychiatric condition (MINI for DSM-V)
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- CIWA-Ar score \> 9
- Use of cannabis, on average, more than 3 days/week over past 3 months
- Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
- Shipley vocabulary score \<18 (corresponds to 5th grade reading level)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 - 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 and older. 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.