Cannabidiol in Opioid Use Disorder and Chronic Pain

StatusCompleted
PhaseEarly Phase 1
Started

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Record History

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  1. Primary and study completion pushed from Aug 31, 2026 to Dec 31, 2027 Show 6 more changesShow less
    • Trial completed
    • Enrollment closed, study ongoing
    • Final enrollment: 23 participants (planned 34)
    • Primary completion date changed from estimate of Dec 31, 2027 to Mar 19, 2025
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 135 words
  2. Primary and study completion dates: Aug 31, 2026 to Dec 31, 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 4 entries
    • Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
  3. Interventions: 1200 mg Cannabidiol (Drug), 400 mg Cannabidiol (Drug), 800 mg Cannabidiol (Drug), Saline (Drug) to 1200 mg Cannabidiol (Drug), 400 mg Cannabidiol (Drug), 800 mg Cannabidiol (Drug), Beta carotene oral solution without CBD (Drug)v20
  4. Re-verified, no change to tracked fieldsv19
  5. Primary endpoints: 5 to 4v18 Show 6 more changesShow less
    • Enrollment target: 40 to 34
    • Interventions: 1200mg Cannabidiol (Drug), 400mg Cannabidiol (Drug), 800mg Cannabidiol (Drug), Saline (Drug) to 1200 mg Cannabidiol (Drug), 400 mg Cannabidiol (Drug), 800 mg Cannabidiol (Drug), Saline (Drug)
    • Eligibility criteria expanded, about 310 words
    • Secondary endpoints: 1 to 8
    • Study description expanded, about 16 words
    • Site contact updated
Show 16 earlier versionsHide 16 earlier versions
  1. Primary completion date: Jan 1, 2026 to Aug 31, 2026
    • Study completion date: Mar 31, 2026 to Aug 31, 2026
    v17
  2. Primary completion date: Mar 31, 2025 to Jan 1, 2026
    • Study completion date: Apr 30, 2025 to Mar 31, 2026
    v16
  3. Primary endpoints: 2 to 5v15 Show 4 more changesShow less
    • Primary completion date: Feb 28, 2025 to Mar 31, 2025
    • Study completion date: Mar 30, 2025 to Apr 30, 2025
    • Secondary endpoints expanded, about 6 words
    • Study description expanded, about 26 words
  4. Primary completion date: Jun 1, 2024 to Feb 28, 2025
    • Study completion date: Jul 1, 2024 to Mar 30, 2025
    v14
  5. Re-verified, no change to tracked fieldsv13
  6. Start date: Nov 8, 2021 to Dec 8, 2021v12
  7. Start date: Nov 15, 2022 to Nov 8, 2021v11
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2022 to Nov 15, 2022
    • Site details revised
    v10
  9. Primary endpoints revised (2)v9
  10. Start date: Aug 1, 2022 to Nov 1, 2022v8
  11. Primary completion date: Jun 1, 2022 to Jun 1, 2024v7 Show 4 more changesShow less
    • Start date: Jun 30, 2021 to Aug 1, 2022
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Aug 31, 2022 to Jul 1, 2024
    • Site details revised
  12. Site contact updatedv6
  13. Collaborators: 1 to 2
    • Study title expanded, about 1 word
    v5
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Dec 31, 2022 to Aug 31, 2022
    • Start date changed from estimate of May 1, 2021 to Jun 30, 2021
    • Site details revised
    v4
  15. Start date: Mar 1, 2021 to May 1, 2021v3
  16. Start date: Dec 1, 2020 to Mar 1, 2021
    • Primary completion date: Nov 1, 2022 to Jun 1, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yale University
490 trials monitored
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This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.
Trial Details
NCT Number NCT04587791
Lead Sponsor Yale University
Collaborators: VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Chronic Pain, Opioid Use Disorder
Related terms Chronic Pain, Opioid-Related Disorders, Pain
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov