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New treatment option for Cannabis Use Disorder
Official title Longitudinal Outpatient Treatment for Cannabis Use Disorder
ClinicalTrials.gov ID: NCT06107062
What this study is testing
What is Cannabidiol - fsCBD?
Cannabidiol - fsCBD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cannabis use disorder.
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 is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
You may be able to join if
- Regular use (at least 4 times per week) of cannabis concentrates for at least the last year.
- Meets DSM5 criteria for at least moderate CUD.
- Currently seeking to cut down or stop cannabis use.
You likely can't join if
- Use of any substance of abuse besides alcohol, nicotine, or cannabis (e.g., cocaine, non-prescription use of opiates, methamphetamine, MDMA...
- Use of CBD-dominant products in the past 90 days, as evidenced by self-report of use of a CBD\>THC product or CBD blood levels at baseline of \>= 5...
- Alcohol use on 3 or more days per week, and/or \> 3 drinks per drinking day in the past 90 days. Participants must also have a breath alcohol level...
- Daily nicotine use.
- Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar...
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
See the full eligibility criteria
- Regular use (at least 4 times per week) of cannabis concentrates for at least the last year.
- Meets DSM5 criteria for at least moderate CUD.
- Currently seeking to cut down or stop cannabis use.
- Use of any substance of abuse besides alcohol, nicotine, or cannabis (e.g., cocaine, non-prescription use of opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 90 days, as indicated by...
- Use of CBD-dominant products in the past 90 days, as evidenced by self-report of use of a CBD\>THC product or CBD blood levels at baseline of \>= 5 ng/mL
- Alcohol use on 3 or more days per week, and/or \> 3 drinks per drinking day in the past 90 days. Participants must also have a breath alcohol level of 0 at the beginning of each study visit.
- Daily nicotine use.
- Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, or major depression with suicidal ideation, or has a history of...
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
- Current use of psychotropics (e.g., antidepressants, anxiogenics), which may dampen effects of CBD.
- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate) or medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen...
- Current or past hepatocellular disease, as indicated by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of the normal range at screening or a history of liver disease...
- For participants assigned female at birth, pregnancy or trying to become pregnant as indicated by a urine pregnancy test administered at the beginning of each study visit.
- History of seizures
- 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...
- Allergy to study medications (hemp seed oil, hemp extract, gelatin, glycerin)
The study team makes the final eligibility decision.
Where it's taking place
- Boulder, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulder, 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.