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Outpatient Treatment for Cannabis Use Disorder with CBD

This study is looking at how different forms of cannabidiol (CBD) might help adults who want to reduce or stop their use of cannabis concentrates. Researchers are comparing two types of plant-derived CBD capsules: full-spectrum CBD (which has a small amount of THC) and broad-spectrum CBD (which has no THC), against a placebo (a pill with no active medicine). You would also receive five weeks of talk therapy for cannabis use disorder (CUD). The main goal is to see if these CBD capsules can reduce cannabis use and CUD symptoms over 8 weeks. You might be able to join if you are 21 or older, use cannabis concentrates regularly, meet criteria for at least moderate CUD, and are looking to cut down or stop using cannabis. The study aims to enroll 165 participants.

Study design
This is a randomized study, meaning participants are randomly assigned to receive full-spectrum CBD, broad-spectrum CBD, or a placebo. It plans to enroll 165 participants.
What's involved
You would participate in the study for 8 weeks, taking capsules and engaging in five weeks of psychotherapy. Blood samples will be collected to measure drug levels and cannabis use.
Compensation
Not stated in the trial record.
Follow-up
After the 8-week treatment period, there will be telehealth follow-up appointments at 12 and 16 weeks.

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NCT06107062

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Recruiting
PHASE2Ages 21+InterventionalTreatment
University of Colorado, Boulder
~165 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Cannabidiol - fsCBDPlaceboCannabidiol - bsCBD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in cannabis use
Measured over 8 weeks
+3 more outcomes measured

Conditions

Cannabis Use Disorder

Explore related trials

Cannabis Use Disorder

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Jonathan Lisano, PhD
[email protected]
303-492-9549
Email the study team

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Do you actually qualify for this trial?

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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)

What this trial measures

  • Difference in cannabis use8 weeks

    The change in the amount of cannabis used by participants as measured by self-report

  • Difference in cannabis use8 weeks

    The change in the amount of cannabis used by participants as measured by biomarkers of metabolites

  • Difference in symptoms of cannabis use disorder (CUD)8 weeks

    The change in symptom levels of CUD as measured by the Cannabis Use Disorders Identification Test (CUDIT). This questionnaire was designed for self administration and is scored by adding each of the 8 items: * Question 1-7 are scored on a 0-4 scale * Question 8 is scored 0, 2 or 4. Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.

  • Difference in withdrawal symptoms8 weeks

    The change in three facets of withdrawal including affective, physiological, and physical withdrawal symptoms as measured by the Marijuana Withdrawal Checklist (MWC)