BridgeMD
New treatment option for Cannabis
Official title Modulation of THC Effects by CBD: a Dose-ranging Study
ClinicalTrials.gov ID: NCT06099379
What this study is testing
What is ∆9-tetrahydrocannabinol?
∆9-tetrahydrocannabinol is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for cannabis.
Also referred to as Cannabidiol.
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 purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.
- Phase 2: a mid-size study of how well it works
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 49. Healthy volunteers may be eligible.
You may be able to join if
- Between 21 and 49 years of age, inclusively;
- Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
- Be able to provide a signed informed consent;
- Willing to comply with study procedures and requirements as per protocol;
- Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
You likely can't join if
- Participants will be excluded if any of the following criteria are met:
- Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the...
- Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current...
- Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or...
- Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening...
- Blood pressure higher than 130/80 mmHg;
See the full eligibility criteria
- Between 21 and 49 years of age, inclusively;
- Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
- Be able to provide a signed informed consent;
- Willing to comply with study procedures and requirements as per protocol;
- Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
- Able to communicate and understand English or French language;
- For female participants: a. No childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation...
- Participants will be excluded if any of the following criteria are met:
- Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the...
- Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);
- Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;
- Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;
- Blood pressure higher than 130/80 mmHg;
- Kidney disorders;
- Bleeding disorders;
- Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;
- Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
- Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
- Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with cannabis.
- Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.
- Resting heart rate over 100 beats per minute.
- Current body mass index (BMI) over 29.9 kg/m2.
- Any clinically significant electrocardiogram abnormalities at screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.