Status:
RECRUITING
Longitudinal Outpatient Treatment for Cannabis Use Disorder
Lead Sponsor:
University of Colorado, Boulder
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 cannab...
Detailed Description
As cannabis legalization continues to spread across the United States, average Δ9-tetrahydrocannabinol (THC) concentrations in recreational products have significantly increased, with THC levels as hi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 self-report and urine toxicology screening (Syva Rapid Test) at baseline.
- 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 treatment for these disorders. Psychiatric disorders will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
- 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, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide).
- 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 irrespective of AST and ALT at the time of screening.
- 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, Primidone), or strong CYP3A inhibitors (e.g., clarithromycin, HIV protease inhibitors, and most antifungals), 2C19 inhibitors (e.g., fluoxetine, Lansoprazole, Tricyclic antidepressants (TCAs))
- Allergy to study medications (hemp seed oil, hemp extract, gelatin, glycerin)
Key Trial Info
Start Date :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06107062
Start Date
May 16 2024
End Date
March 31 2029
Last Update
June 19 2025
Active Locations (1)
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1
University of Colorado Boulder
Boulder, Colorado, United States, 80301