ACTIVE_NOT_RECRUITING

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-28

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05712707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Sandra Comer, Ph.D

PRINCIPAL_INVESTIGATOR

Columbia University / New York State Psychiatric Institute

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Clinilabs

Eatontown, New Jersey, 07724

United States

CenExel HRI

Marlton, New Jersey, 08053

United States

New York State Psychiatric Institute

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: New York State Psychiatric Institute

Sandra Comer, Ph.D, PRINCIPAL_INVESTIGATOR, Columbia University / New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2023-02-28

Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use Disorder
Opioid Withdrawal