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NCT05076370 · ClinicalTrials.gov registry record · Early Phase 1

Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine

A Early Phase 1 study of Addiction, sponsored by Yale University.

Completed
Registry status
Early Phase 1
Development phase
7
Enrollment target
1
Study location

NCT05076370: Completed Early Phase 1 study of Addiction, sponsored by Yale University.

NCT05076370 is a Early Phase 1 study of Addiction that has completed, run by Yale University. The registered enrollment target is 7 participants, below the 692-participant average among 16 other Addiction trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05076370, a Early Phase 1 study of Addiction, has completed, sponsored by Yale University.

COMPLETED
Registry status
Early Phase 1
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving methadone or buprenorphine.

Primary Outcome

The ACES consists of a single item that rates overall agitation and sedation of the participant at the time of evaluation, where 1 indicates marked agitation; 2: moderate agitation; 3: mild agitation; 4: normal behavior; 5: mild calmness; 6: moderate calmness; 7: marked calmness; 8: deep sleep; and 9: unarousable. Clinically significant sedation was a priori defined as an ACES score of 7 (marked calmness) or higher at any point during the session. A score was averaged across all time intervals.

Conditions Studied

Addiction

Interventions

  • DRUG CBD Day 1
  • DRUG CBD Day 2
  • DRUG CBD Day 3

Study Locations (1)

Connecticut

  • Veteran Affairs Hospital - West Haven

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2021-12-08
Est. Completion 2024-06-28
Phase Early Phase 1
Yale University

1,492 total trials

What the finished NCT05076370 record still lists

NCT05076370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 692-participant average among 16 other Addiction trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Addiction appearing as the primary indexed condition, and to 3 interventions - of which CBD Day 1 is the first listed.

NCT05076370 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT05076370 about?

NCT05076370 is a clinical study titled "Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine". The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effect...

What is the current status of trial NCT05076370?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2021-12-08. Estimated completion is 2024-06-28.

What conditions does trial NCT05076370 study?

This clinical trial studies the following conditions: Addiction.

What interventions are being tested in trial NCT05076370?

The interventions under investigation include: CBD Day 1 (DRUG), CBD Day 2 (DRUG), CBD Day 3 (DRUG).

Who is sponsoring clinical trial NCT05076370?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05076370 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Addiction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05076370's enrollment target sits among peer trials

7 17th of 16 the lowest of 16 other Addiction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Addiction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05076370, the US trial registry maintained by the National Library of Medicine. NCT05076370 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.