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Cannabidiol in the Treatment of Opioid Use Disorder

NCT06206291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-12-19

No results posted yet for this study

Summary

The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.

Conditions

Interventions

DRUG

Placebo

Matching placebo twice daily for first 4 weeks

DRUG

Cannabidiol (CBD) 200mg

First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.

DRUG

Cannabidiol (CBD) 400mg

Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Sponsors & Collaborators

  • Yasmin Hurd

    lead OTHER

Principal Investigators

  • Yasmin Hurd, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2024-12-04
Completion
2024-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206291 on ClinicalTrials.gov