BridgeMD
New treatment option for Sleep
Official title Cannabis for Palliative Care in Cancer
ClinicalTrials.gov ID: NCT06266611
What this study is testing
What is fsCBD Cannabidiol?
fsCBD Cannabidiol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sleep.
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
- Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- Able to provide informed consent
- Aged ≥25 years at Visit 1 (Baseline)
- Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
- Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
- Desire to use cannabis to treat their symptoms
You likely can't join if
- Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide...
- Current use of anti-psychotic medications
- Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor...
- Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits
See the full eligibility criteria
- Able to provide informed consent
- Aged ≥25 years at Visit 1 (Baseline)
- Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
- Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
- Desire to use cannabis to treat their symptoms
- Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
- Willing to practice acceptable methods of birth control until completing study medication
- Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
- Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
- Current use of anti-psychotic medications
- Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital...
- Liver function tests (Alanine transaminase [ALT] and Aspartate transaminase [AST]) levels ≥2x the upper normal limits
- Moderate or severe liver disease
- Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
- History of seizures
- For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12...
- Physician response to passive consent indicating contraindications for participation.
- Unwilling to refrain from cannabis use other than study drug for the entire study duration
- Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, 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, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, 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.