160 Participants Needed

Sublingual Dexmedetomidine for Opioid Withdrawal

Recruiting at 3 trial locations
GM
JJ
HH
Overseen ByHoward Hassman, D.O., AOBFP
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: New York State Psychiatric Institute
Must be taking: Opioids
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, it mentions that the use of any medication that may impact safety or interfere with the trial is not allowed, so you should discuss your current medications with the trial investigators.

Is sublingual dexmedetomidine safe for treating opioid withdrawal?

Sublingual dexmedetomidine has been studied for safety in treating opioid withdrawal, with some participants experiencing mild to moderate side effects like low blood pressure and drowsiness. In rare cases, severe side effects like low heart rate and low blood pressure occurred, but overall, it was generally well-tolerated.12345

How is the drug dexmedetomidine unique in treating opioid withdrawal?

Dexmedetomidine is unique because it is administered sublingually (under the tongue) and works by targeting alpha-2 adrenergic receptors, which may reduce opioid withdrawal symptoms with fewer heart-related side effects compared to other treatments.15678

What data supports the effectiveness of the drug dexmedetomidine for treating opioid withdrawal?

Research shows that sublingual dexmedetomidine (BXCL501) can reduce opioid withdrawal symptoms, with higher doses leading to significant improvements in withdrawal scores. Additionally, dexmedetomidine has been effective in managing withdrawal symptoms in both adults and infants in various settings, suggesting its potential usefulness for opioid withdrawal.13567

Who Is on the Research Team?

SC

Sandra Comer, Ph.D

Principal Investigator

Columbia University / New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with moderate-to-severe opioid use disorder who are physically dependent on opioids. Participants must understand the study and agree to contraception if applicable. Exclusions include methadone or buprenorphine in urine, pregnancy, significant medical conditions, abnormal ECGs, liver issues, recent naltrexone use, certain medication uses that affect safety or trial outcomes, psychiatric disorders affecting study compliance, alcohol/benzodiazepine detox need, recent other clinical trial participation and specific cardiac history.

Inclusion Criteria

I understand and can follow the study's requirements.
I agree to use birth control during the study.
Has moderate-to-severe opioid use disorder (304.00) as per DSM-V, and physiological dependence on opioids.

Exclusion Criteria

You have a severe psychiatric disorder, such as depression or mania, that may make it difficult for you to complete the study requirements.
You have participated in another clinical trial with a drug in the last 30 days before screening.
I have a history of significant heart issues or my heart rate/blood pressure doesn't meet the specified range.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sublingual BXCL501, placebo, or lofexidine during a 7-day inpatient withdrawal period using a methadone taper

1 week
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine
Trial Overview The trial tests BXCL501 (dexmedetomidine sublingual film) against lofexidine and a placebo to see which better reduces opioid withdrawal symptoms without severe side effects like low blood pressure. Over seven days inpatient treatment at three sites will compare their safety and efficacy in individuals withdrawing from opioids.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BXCL501 (240 micrograms)Experimental Treatment1 Intervention
Group II: BXCL501 (180 micrograms)Experimental Treatment1 Intervention
Group III: Lofexidine (Positive Control)Active Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Precedex for:
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Approved in United States as Precedex for:
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Approved in Canada as Precedex for:
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Approved in Japan as Precedex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

CenExel HRI

Collaborator

Trials
1
Recruited
160+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

BioXcel Therapeutics Inc

Industry Sponsor

Trials
20
Recruited
2,400+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

Clinilabs, Inc.

Collaborator

Trials
9
Recruited
650+

Published Research Related to This Trial

Dexmedetomidine, an alpha 2 adrenergic agonist, is primarily approved for sedation during mechanical ventilation in adults, but it may also be effective in managing substance withdrawal symptoms in intensive care settings.
In a small case series involving 3 patients after cardiothoracic surgery, dexmedetomidine was used to successfully control withdrawal behavior, suggesting its potential as a treatment option for withdrawal in critically ill patients.
Dexmedetomidine in the treatment of withdrawal syndromes in cardiothoracic surgery patients.Baddigam, K., Russo, P., Russo, J., et al.[2013]
In a study of 73 patients undergoing laparoscopic bariatric surgery, those who received dexmedetomidine experienced a significant reduction in narcotic use (66 mg vs 130 mg of morphine equivalents) and were more likely to meet discharge criteria on the first postoperative day (61% vs 26%).
Dexmedetomidine was found to be safe and effective in minimizing narcotic requirements and potentially reducing hospital stay duration, which is particularly beneficial for patients with a high risk of respiratory complications, such as those with obstructive sleep apnea.
The impact of perioperative dexmedetomidine infusion on postoperative narcotic use and duration of stay after laparoscopic bariatric surgery.Dholakia, C., Beverstein, G., Garren, M., et al.[2018]
In a study of seven infants aged 3 to 24 months experiencing opioid withdrawal after sedation during mechanical ventilation, dexmedetomidine effectively controlled withdrawal symptoms, with Finnegan scores dropping to ≤7 after treatment.
No adverse hemodynamic or respiratory effects were observed, suggesting that dexmedetomidine is a safe and viable option for managing opioid withdrawal in pediatric intensive care settings.
Dexmedetomidine to treat opioid withdrawal in infants following prolonged sedation in the pediatric ICU.Tobias, JD.[2019]

Citations

Dexmedetomidine in the treatment of withdrawal syndromes in cardiothoracic surgery patients. [2013]
The impact of perioperative dexmedetomidine infusion on postoperative narcotic use and duration of stay after laparoscopic bariatric surgery. [2018]
Dexmedetomidine to treat opioid withdrawal in infants following prolonged sedation in the pediatric ICU. [2019]
Sublingual dexmedetomidine (BXCL501) reduces opioid withdrawal symptoms: findings from a multi-site, phase 1b/2, randomized, double-blind, placebo-controlled trial. [2023]
Subcutaneous dexmedetomidine infusions to treat or prevent drug withdrawal in infants and children. [2019]
Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]
Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]
Ultra-rapid opiate detoxification using dexmedetomidine under general anesthesia. [2015]
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