A Study of Cannabidiol in Young Adult Cannabis Users

NCT06569394 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 23-09541P50DA056408
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (3)

• Difference in blood THC-COOH levels

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

  8 weeks

• 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.

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

• Difference in cannabis use

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

  8 Weeks

Other Outcomes (2)

• Adverse effects

  8 weeks

• Difference in blood CBD levels

  8 weeks

Study Arms (2)

Broad Spectrum Cannabidiol (bsCBD) 400 mg

ACTIVE COMPARATOR

bsCBD in a 400 mg dose will be used as described in the study arms.

Drug: Broad Spectrum Cannabidiol (bsCBD) 400 mg

Placebo

PLACEBO COMPARATOR

A medically inert placebo medication will be used as described in the study arms.

Drug: Placebo

Interventions

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.

Broad Spectrum Cannabidiol (bsCBD) 400 mg

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
• Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medication.
• 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) or a history of seizures.
• Current or past hepatocellular disease, as indicated by medical history or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than two times the upper limit of the normal range at screening.
• For female participants, currently lactating.
• For female patients of childbearing potential, not willing to use at least one approved method of birth control while taking the study medication, unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year).
• Current suicidality risk as indicated during the conduct of the C-SSRS with concurrence after a study physician's or PI evaluation if the response to C-SSRS questions 1 or 2 is "yes"

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Christian J Hopfer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian J Hopfer, MD

CONTACT

303-724-3170; christian.hopfer@cuanschutz.edu

Kristen M Raymond, BA

CONTACT

303-724-3196; kristen.raymond@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blind to medication assignment, as will all care providers and investigators.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind placebo controlled clinical trial

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)