BridgeMD
New treatment option for Cannabis, Drug Effects
Official title Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (Δ9-THC) With and Without Alcohol on Perception and Driving Performance in Healthy Adults
ClinicalTrials.gov ID: NCT07176208
What this study is testing
What is 5 mg Dronabinol (Marinol®) + Alcohol Beverage?
5 mg Dronabinol (Marinol®) + Alcohol Beverage is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cannabis, drug effects.
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
- With the increasing prevalence and use of cannabis products by the public, there exists a need to better understand the safety impact of cannabis use, particularly when it comes to subjective perceptions of drug effect and driving impairment. This study aims to evaluate the dose-dependent effects of oral Δ9-THC alone and in combination with alcohol (0.08% BAC [Blood Alcohol Concentration]) on driving performance and subjective feeling in healthy adults.
- 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
- Subject signs an IRB approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and...
- Subject is a healthy, non-smoking man or woman, 21 to 55 years of age, inclusive, who weighs at least 50 kg (110 lbs) and has a body mass index of...
- Subject possesses a valid U.S. driver's license and has driven a minimum of 600 miles per year for the previous 3 years.
- During screening people will be assessed using a driving simulation test. Subject must not demonstrate any motion sickness as determined by the...
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead ECG results, and physical examination...
You likely can't join if
- A history of cannabis use disorder or use of any psychoactive drug in the last month.
- Any reported history of alcohol intolerance.
- Alcohol intolerance as detected by ethanol patch testing.
- Subject has a dry mouth or history of salivary gland disfunction or surgery.
- A history of any psychiatric diagnosis, including mood, anxiety, and psychotic disorders.
- Any family history of schizophrenia or other psychotic illness.
See the full eligibility criteria
Who can join
- Subject signs an IRB approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) before any study related procedures are...
- Subject is a healthy, non-smoking man or woman, 21 to 55 years of age, inclusive, who weighs at least 50 kg (110 lbs) and has a body mass index of 18.5 to 33.0 kg/m2, inclusive, at Screening and check-in (Day -1).
- Subject possesses a valid U.S. driver's license and has driven a minimum of 600 miles per year for the previous 3 years.
- During screening people will be assessed using a driving simulation test. Subject must not demonstrate any motion sickness as determined by the investigator and defined in the driving simulation operations manual and...
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening and check-ins or, if abnormal, the abnormality is...
- Subject is an occasional user of cannabis, defined as having at least one cannabis exposure within the last 6 months, but no daily use pattern and no cannabis exposure within the past month.
- Subject has consumed alcohol equivalent to achieving approximately 0.10% BAC (approximately 3-4 standard drinks for females and 4-5 drinks for males over 1-2 hours) within the past year without experiencing significant...
- Subject must report at least 1 instance of simultaneous alcohol and cannabis use over the past one year without experiencing significant adverse reactions based on investigator discretion.
- Participants must agree to refrain from using any of the following for the duration of the study: alcohol, nicotine containing products, marijuana (except for provided study drug) or marijuana-derived products, hemp or...
- Subject must test negative for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) by a rapid antigen test at check-in. If a subject's test comes back as invalid, the test can be repeated.
- Female people must be of non-childbearing potential (non-childbearing potential includes post-menopausal females defined as spontaneous amenorrhea for at least 12 months with FSH in the post-menopausal range or females...
- Male people must agree to practice 2 effective methods of birth control (as determined by the investigator or designee) beginning at check-in (Day -1) until at least 3 months after the last dose of study drug. Subject...
- Subject agrees to and is highly likely (as determined by the investigator) to comply with the protocol defined procedures and to complete the study.
What rules you out
- A history of cannabis use disorder or use of any psychoactive drug in the last month.
- Any reported history of alcohol intolerance.
- Alcohol intolerance as detected by ethanol patch testing.
- Subject has a dry mouth or history of salivary gland disfunction or surgery.
- A history of any psychiatric diagnosis, including mood, anxiety, and psychotic disorders.
- Any family history of schizophrenia or other psychotic illness.
- Any history of seizures, epilepsy, or traumatic brain injury.
- History of syncope within 3 months prior to screening or any history of recurrent and/or unexplained episodes of syncope.
- A positive test result for alcohol and drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, alcohol, opiates, phencyclidine, propoxyphene, methadone, ) at screening and check-in (Day -1).
- Use or intend to use any medications other than birth control, including prescription, OTC, herbal or recreational products (excluding cannabis) in the 14 days prior to check-in (Day -1), unless deemed acceptable by the...
- Currently participating in another clinical study of an investigational drug or has been treated with any investigational drug within 30 days or 5 half-lives (whichever is longer) of dosing for this study.
- Subject has used nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, electronic cigarettes) within 6 weeks of Screening. people must refrain from using these throughout the study.
- Subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance of music, television, movies, games, and activities that may cause excitement, emotional tension, or arousal during the...
- Subject has known or suspected allergies or sensitivities to the study drug, delta 9-THC or sesame seeds/oil.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months before Screening, has a history of alcohol use disorder or drug/chemical/substance abuse within 2 years before...
- Subject tests positive for potential active alcohol use disorder (as determined by a score of 3 or greater on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C).
- Subject has a history of suicidal ideation or previous suicide attempts.
- Subject has a history or evidence of a clinically significant disorder, condition, or disease (e.g., cancer, human immunodeficiency virus [HIV], hepatic or renal impairment) that, in the opinion of the investigator...
- Subject has a diagnosis of COVID-19 or any signs or symptoms that are consistent with COVID-19 per CDC recommendations at screening or check-in (Day -1). These include people with fever or chills, cough, shortness of...
- Subject has any condition possibly affecting study drug absorption (e.g., gastrectomy, Crohn's disease, irritable bowel syndrome).
- Subject has clinical laboratory test results (hematology, serum chemistry and urinalysis) at screening or check-ins that are outside the reference ranges provided by the clinical laboratory and considered clinically...
- Subject has a mean systolic blood pressure \ 140 mmHg or a mean diastolic blood pressure \ 90 mmHg at either screening or check-ins, unless determined not clinically significant per investigator. Blood pressure will be...
- Subject has a positive test result at screening for HIV 1 or 2 antibody, hepatitis C virus antibodies, or hepatitis B surface antigen.
- Subject is unable or unwilling to undergo multiple venipunctures for blood sample collection because of poor side effects or is unlikely to complete the study due to poor venous access.
- Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days before check-in.
- Subject with any visual or hearing impairment that will prevent accurate completion of study assessments (as determined by the investigator).
- Subject has any other condition that precludes his or her participation in the study (as determined by the investigator).
The study team makes the final eligibility decision.
Where it's taking place
- West Bend, Wisconsin, 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 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 West Bend, Wisconsin, 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.