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NCT04470050 · ClinicalTrials.gov registry record · Phase 1
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
A Phase 1 study of Opioid Withdrawal, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
- 3
- Study locations
NCT04470050: Completed Phase 1 study of Opioid Withdrawal, sponsored by BioXcel Therapeutics.
NCT04470050 is a Phase 1 study of Opioid Withdrawal that has completed, run by BioXcel Therapeutics. The registered enrollment target is 225 participants, above the 100-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (125% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04470050, a Phase 1 study of Opioid Withdrawal, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
- 3
- Study locations
Study Summary
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo phase (Phase 2) included Days 6-12. The randomized phase was followed by 2 sequential days, Days 13 and 14, utilizing treatment of BXCL501-placebo sublingual films and morphine-placebo capsules for all subjects who remained in the study.
Primary Outcome
Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexmedetomidine
Study Locations (3)
Florida
- BioXcel Clinical Research Site - Miami Lakes
New Jersey
- BioXcel Clinical Research Site - Marlton
New York
- BioXcel Clinical Research Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2021-02-18 |
| Phase | Phase 1 |
What the finished NCT04470050 record still lists
NCT04470050 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (125% higher).
The record links to 1 condition, with Opioid Withdrawal appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04470050 reports a single indexed study location in Florida, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT04470050 about?
NCT04470050 is a clinical study titled "Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal". This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo pha...
What is the current status of trial NCT04470050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2020-06-09. Estimated completion is 2021-02-18.
What conditions does trial NCT04470050 study?
This clinical trial studies the following conditions: Opioid Withdrawal.
What interventions are being tested in trial NCT04470050?
The interventions under investigation include: Placebo (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT04470050?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04470050 being conducted?
This trial has 3 study locations across Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Withdrawal
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 NCT04470050's enrollment target sits among peer trials
225 2nd of 9 the highest of 9 other Opioid Withdrawal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Withdrawal 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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