Longitudinal Outpatient Treatment for Cannabis Use Disorder

Launched by UNIVERSITY OF COLORADO, BOULDER · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of different forms of hemp-derived CBD (cannabidiol) and THC (Delta-9-tetrahydrocannabinol) on helping adults who frequently use cannabis concentrates and want to reduce their use. Over an 8-week period, participants will receive either full spectrum CBD, broad spectrum CBD, or a placebo (a treatment without active ingredients) while also participating in psychotherapy sessions aimed at addressing cannabis use disorder (CUD). The goal is to see which treatment, if any, helps reduce cannabis use and improve symptoms of CUD.

To be eligible for this study, participants should be adults who have used cannabis concentrates at least four times a week for the past year and are seeking to cut back or stop their use. Certain conditions, such as recent use of other substances or specific health issues, may prevent someone from joining the trial. Throughout the study, participants will have regular check-ins, provide blood samples, and complete questionnaires about their health and cannabis use. This research aims to better understand how these treatments may help individuals struggling with cannabis use.

Gender

ALL

Eligibility 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)