Longitudinal Outpatient Treatment for Cannabis Use Disorder

• Status: Recruiting
• Trial end date: 2029-03-31
• Target enrollment: 0
• Participant gender: All

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 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. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Boulder
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cannabidiol

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)