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NCT05712707 · ClinicalTrials.gov registry record · Phase 1
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
A Phase 1 study of Opioid Use Disorder and Opioid Withdrawal, sponsored by New York State Psychiatric Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 4
- Study locations
NCT05712707: Active Phase 1 study of Opioid Use Disorder and Opioid Withdrawal, sponsored by New York State Psychiatric Institute.
NCT05712707 is a Phase 1 study of Opioid Use Disorder and Opioid Withdrawal that is active but no longer recruiting, run by New York State Psychiatric Institute. The registered enrollment target is 160 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712707, a Phase 1 study of Opioid Use Disorder and Opioid Withdrawal, is active but no longer recruiting, sponsored by New York State Psychiatric Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 4
- Study locations
Study Summary
A major challenge to seeking treatment for opioid use disorder (OUD) is the withdrawal symptoms associated with cessation of opioid use. The signs and symptoms of opioid withdrawal include irritability, anxiety, muscular and abdominal pains, chills, nausea, diarrhea, yawning, runny eyes and nose, sweating, sneezing, weakness, and insomnia. The current gold standard of treatment involves a gradual reduction of the opioid drug dosage (tapering). However, as all opioids have potential for abuse and require careful dosing due to side effects (e.g., respiratory depression), a non-opioid medication to facilitate withdrawal severity would be of great value. Commonly used non-opioid medications like lofexidine have concerning side effects including sedation and low blood pressure. BioXcel Therapeutics has developed BXCL501 (dexmedetomidine: sublingual film) to reduce symptoms associated with opioid withdrawal. Dexmedetomidine is currently used as an intravenous anesthetic for its anxiety-reducing, sedative, and analgesic properties. The current study will seek to compare the safety and efficacy of BXCL501 relative to lofexidine and placebo in subjects with OUD who are physically dependent on opioids. Throughout a 7-day inpatient withdrawal period (using a methadone taper) opioid-dependent participants will receive sublingual BXCL501, placebo, or lofexidine. In comparison to lofexidine, dexmedetomidine is expected to have a superior safety profile with limited adverse effects on blood pressure and heart rhythm. Three sites will participate in this study: NYSPI, Clinilabs, Inc., and Yale University. The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Primary Outcome
Establish the safety of BXCL501 relative to placebo and lofexidine in subjects with OUD who are physically dependent on opioids as measured by the frequency of adverse events.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BXCL501 (180 micrograms)
- DRUG BXCL501 (240 micrograms)
- OTHER Lofexidine (Positive Control)
Study Locations (4)
New Jersey
- Clinilabs - Eatontown
- CenExel HRI - Marlton
Connecticut
- Yale University - New Haven
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
What the registry record for NCT05712707 still lists
NCT05712707 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05712707 reports a single indexed study location in New Jersey, Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT05712707 about?
NCT05712707 is a clinical study titled "Sublingual Dexmedetomidine for Treating Opioid Withdrawal". A major challenge to seeking treatment for opioid use disorder (OUD) is the withdrawal symptoms associated with cessation of opioid use. The signs and symptoms of opioid withdrawal include irritability, anxiety, muscular and abdominal pains, chills, nausea, diarrhea, yawning, runny eyes and nose, sw...
What is the current status of trial NCT05712707?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2023-02-28. Estimated completion is 2026-08-31.
What conditions does trial NCT05712707 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Withdrawal.
What interventions are being tested in trial NCT05712707?
The interventions under investigation include: Placebo (OTHER), BXCL501 (180 micrograms) (DRUG), BXCL501 (240 micrograms) (DRUG), Lofexidine (Positive Control) (OTHER).
Who is sponsoring clinical trial NCT05712707?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05712707 being conducted?
This trial has 4 study locations across Connecticut, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
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 NCT05712707's enrollment target sits among peer trials
160 106th of 257 higher than 149 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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