Using sublingual dexmedetomidine to treat opioid withdrawal symptoms

Phase 1B Study of Sublingual Dexmedetomidine, an Alpha 2 Adrenergic Agonist, for Treating Opioid Withdrawal

This study is testing if a new under-the-tongue medication can help people with opioid withdrawal feel better without using other opioids.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: New York State Psychiatric Institute (Academic / other)
• Locations: 4 sites (New Haven, Connecticut and 3 other locations)
• Trial ID: NCT05712707 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of BXCL501, a sublingual formulation of dexmedetomidine, in alleviating withdrawal symptoms associated with opioid use disorder. The study aims to provide a non-opioid alternative to current treatment methods, which often involve tapering with opioid substitutes. Participants will receive either the active medication or a placebo, and their withdrawal symptoms will be monitored throughout the trial. The goal is to determine if dexmedetomidine can effectively reduce the severity of withdrawal symptoms compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 with moderate-to-severe opioid use disorder and physiological dependence on opioids.

Not a fit: Patients with significant cardiac conditions or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly ease the withdrawal process for patients with opioid use disorder, potentially improving treatment adherence and outcomes.

How similar studies have performed: While the use of dexmedetomidine for opioid withdrawal is a novel approach, other studies have explored non-opioid medications for similar purposes, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Capable of understanding and complying with the protocol.
* 18 years of age or older but less than 60 years old.
* Has opioid use disorder moderate-to-severe (304.00) as per DSM-V, and physiological dependence on opioids.
* Females agree to use an acceptable method of contraception for the duration of the study.

Exclusion Criteria:

* Positive urine or serum pregnancy test at screening, after admission, planning to become pregnant during the course of the trial, or currently breast feeding.
* Clinically significant history of cardiac disease, including syncope, bradycardia, conduction abnormalities, orthostatic hypotension or blood pressure disorders. Heart rate and blood pressure at screening and baseline of \< 50 beats per minute or systolic blood pressure \<105, \>150 mmHg or diastolic BP \<70, \>90 mmHg.
* Clinically significant medical condition or observed abnormalities (including: physical examination, hypotension, laboratory evaluation, and/or urinalysis findings). Clinically significant abnormal ECG such as second- or third-degree heart block, uncontrolled arrhythmia, or QTc interval \> 450 msec for males, and \> 470 msec for females.
* Evidence of hepatic abnormalities, including: ascites, bilirubin \>10% above upper limit of normal and/or esophageal variceal disease, active hepatitis/aspartate aminotransferase, alanine aminotransferase \>3x the upper limit of normal.
* Any psychiatric disorder that would compromise ability to complete study requirements \[e.g. severe acute depression, active mania, or suicidality with specific plan and intent (assessed using the CSSRS)\].
* Not being able to provide a negative urine for methadone or buprenorphine at screening.
* Use of oral naltrexone for ≥7 consecutive days within 60 days prior to screening.
* Need for alcohol or benzodiazepine detoxification.
* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening.
* Use of any concomitant medication at screening or anticipated/required use during the study period that the investigators feel may impact participant safety or interfere with the aims of the trial (e.g., daily licit or illicit benzodiazepine use).
* Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the protocol visit schedule or visit requirements.
* Investigator-site personnel or immediate family of investigator-site personnel.

Where this trial is running

New Haven, Connecticut and 3 other locations

• Yale University — New Haven, Connecticut, United States (Recruiting)
• Clinilabs — Eatontown, New Jersey, United States (Recruiting)
• CenExel HRI — Marlton, New Jersey, United States (Recruiting)
• New York State Psychiatric Institute — New York, New York, United States (Active_not_recruiting)

Study contacts

• Principal investigator: Sandra Comer, Ph.D — Columbia University / New York State Psychiatric Institute
• Study coordinator: Gabriela Madera

Conditions Opioid Use Disorder; Opioid Withdrawal