Treatment for Cannabis Use Disorder with Cannabidiol
Hemp-derived Cannabidiol for the Treatment of Cannabis Use Disorder: A Double-blind Placebo-controlled Randomized Trial
This study is testing if a hemp-based treatment with or without THC can help adults who regularly use cannabis reduce their use and improve their symptoms of cannabis use disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Boulder Academic / other |
| Drugs / interventions | pexidartinib |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT06107062 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC) in reducing cannabis use and symptoms of cannabis use disorder (CUD) in adults who regularly use cannabis concentrates. Participants will be randomly assigned to receive either full spectrum CBD, broad spectrum CBD, or a placebo over an 8-week period, with additional psychotherapy treatment for CUD. The study includes telehealth follow-ups and assessments of drug exposure and various psychological and physical health measures. This research aims to address the lack of effective treatments for individuals with high potency cannabis use.
Who should consider this trial
Good fit: Ideal candidates are adults who have been using cannabis concentrates regularly for at least a year and are seeking to reduce or stop their cannabis use.
Not a fit: Patients who have used other substances of abuse recently or have a psychotic disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, accessible option for individuals struggling with cannabis use disorder.
How similar studies have performed: Previous studies have shown promising results with CBD in reducing cannabis use, but this approach using widely available hemp-derived CBD is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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)
Where this trial is running
Boulder, Colorado
- University of Colorado Boulder — Boulder, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Jonathan Lisano, PhD
- Email: Jonathon.Lisano@colorado.edu
- Phone: 303-492-9549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.