Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a dose-ranging study to support the safety and efficacy evaluation of BXCL501 to treat the symptoms of acute opioid withdrawal. The BXCL501-201 study is designed to characterize the efficacy, safety, tolerability, and pharmacokinetics of escalating doses of BXCL501 (sublingual film formulation of DEX, HCl) versus placebo following discontinuation of morphine maintenance in patients with opioid use disorder who are physically dependent on opioids.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcel Therapeutics Inc
• Collaborator: Cognitive Research Corporation
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

A patient will be eligible for inclusion in the study if he or she meets the following criteria:

1. Male and female patients between the ages of 18-64, inclusive.

2. Patients who have met DSM-5 criteria for moderate to severe opioid use disorder confirmed by the Mini-International Neuropsychiatric Interview (MINI) with physiological dependence as evidenced by a Clinical Opiate Withdrawal (COWS) score of >5 or a positive naloxone challenge upon inpatient admission.

3. Patients who read, understand, and provide written informed consent.

4. Participants who agree to use a medically acceptable and effective birth control method.

Exclusion Criteria:

A patient will be excluded from the study if he or she meets the following criteria:

1. Female patients who have a positive urine pregnancy test at screening or when tested or currently breast feeding.

2. Clinically significant history of cardiac disease.

3. History or presence of a significant medical disease or disorder.

4. Hepatic dysfunction at the screening visit.

5. Acute active Hepatitis B or C.

6. Patients with ECG abnormalities considered clinically significant by the investigator.

7. Any psychiatric disorder that would compromise ability to complete study requirements.

8. Currently meets DSM-5 criteria for substance abuse disorder, moderate or severe, for any substance other than opioids, caffeine, or nicotine.

9. History of suicidal behavior within the last 1 year prior to screening.

10. Patients who have received an investigational drug within 30 days prior to screening.

11. Use of any excluded medication at screening or anticipated/required use during the study period.

12. Patients with a history of intolerance to morphine.

13. Any finding that, in the view of the investigator, would compromise the patient's ability to fulfill the protocol visit schedule or visit requirements.