Cannabidiol and Cannabis Concentrate Users

NCT06575751 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 23-09531P50DA056408
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (3)

• Difference in blood 11-Nor-9-carboxy-THC (THC-COOH) levels

  THC-COOH levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion

  4 weeks

• Difference in blood delta-9-tetrahydrocannabinol (THC) levels

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

  4 weeks

• Difference in cannabis use

  Total number of days of cannabis use during the 4-week medication period as reported on daily diaries

  4 weeks

Secondary Outcomes (5)

• Difference in cannabis-induced intoxication

  4 weeks

• Difference in cannabis-induced subjective effects

  4 weeks

• Difference in cannabis-induced psychotomimetic symptoms

  4 weeks

• Difference in cannabis-induced anxiety and negative affect

  4 weeks

• Difference in cannabis craving

  2 weeks

Other Outcomes (2)

• Difference in blood cannabidiol (CBD) levels

  4 weeks

• Adverse effects

  4 weeks

Study Arms (3)

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

Broad Spectrum Cannabidiol (bsCBD) 200 mg

ACTIVE COMPARATOR

bsCBD in a 200 mg dose will be used as described in the study arms.

Drug: Broad Spectrum Cannabidiol (bsCBD) 200 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

Broad Spectrum Cannabidiol (bsCBD) 200 mg DRUG

Participants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.

Broad Spectrum Cannabidiol (bsCBD) 200 mg

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 25-60.
• Regular use (at least 4 times per week) of cannabis concentrates for the last year.
• Not currently seeking to cut down or stop cannabis use.
• At least one episode of 3 consecutive days of cannabis abstinence with no experience of severe withdrawal symptoms (i.e., \>=4 DSM-5 Cannabis Withdrawal symptoms rated as "severe"), in the last 90 days.
• 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.
• Use of CBD-containing products other than cannabis concentrates in the past 90 days.
• 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, or major depression with suicidal ideation, or has a history of treatment for these disorders.
• Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
• Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medications.
• Currently 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) or aspartate aminotransferase (AST) \> 2 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 an 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

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

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Joseph P Schacht, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph P Schacht, PhD

CONTACT

303-724-3773; joseph.schacht@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 28, 2024
• Study Start: December 4, 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)