Health TrialsbyHealthPanel

A Study of Cannabidiol in Young Adult Cannabis Users

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Colorado, Denver

About this trial

The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18-25

Must have used cannabis flower or concentrates at least five days per week for the past year.

Currently not seeking to cut down or stop cannabis use

At least two symptoms of a DSM-5 cannabis use disorder

Disqualifiers

Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine, opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60 days, as indicated by self-report and urine toxicology screening at the beginning of each study visit.

Alcohol use on 3 or more days per week, and/or >3 drinks per drinking day in the past 60 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, major depression with suicidal ideation, or a history of treatment for these disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Broad Spectrum Cannabidiol (bsCBD) 400 mg

    Drug

    Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.

  • Placebo

    Drug

    Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Broad Spectrum Cannabidiol (bsCBD) 400 mgActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in blood THC-COOH levels

THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion.

Time frame
8 weeks
2

Difference in blood THC levels

THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion.

Time frame
1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
3

Difference in cannabis use

Total number of days of cannabis use during the 8-week medication period as reported on daily diaries.

Time frame
8 Weeks

Secondary outcomes

Other outcomes

1

Adverse effects

Adverse effects reported at Week 4 and Week 8 of medication ingestion

Time frame
8 weeks
2

Difference in blood CBD levels

CBD levels in blood samples collected at Week 4 and Week 8 of medication ingestion

Time frame
8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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