Phase
Condition
Opioid Use Disorder
Treatment
BXCL501 (240 micrograms)
Placebo
BXCL501 (180 micrograms)
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 physiologicaldependence on opioids.
Females agree to use an acceptable method of contraception for the duration of thestudy.
Exclusion
Exclusion Criteria:
Positive urine or serum pregnancy test at screening, after admission, planning tobecome 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. Heartrate and blood pressure at screening and baseline of < 50 beats per minute orsystolic 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 urinalysisfindings). Clinically significant abnormal ECG such as second- or third-degree heartblock, uncontrolled arrhythmia, or QTc interval > 450 msec for males, and > 470 msecfor females.
Evidence of hepatic abnormalities, including: ascites, bilirubin >10% above upperlimit of normal and/or esophageal variceal disease, active hepatitis/aspartateaminotransferase, alanine aminotransferase >3x the upper limit of normal.
Any psychiatric disorder that would compromise ability to complete studyrequirements [e.g. severe acute depression, active mania, or suicidality withspecific plan and intent (assessed using the CSSRS)].
Not being able to provide a negative urine for methadone or buprenorphine atscreening.
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 toscreening.
Use of any concomitant medication at screening or anticipated/required use duringthe study period that the investigators feel may impact participant safety orinterfere with the aims of the trial (e.g., daily licit or illicit benzodiazepineuse).
Any finding that, in the view of the principal investigator, would compromise thesubject's ability to fulfill the protocol visit schedule or visit requirements.
Investigator-site personnel or immediate family of investigator-site personnel.
Study Design
Study Description
Connect with a study center
Yale University
New Haven, Connecticut 06519
United StatesActive - Recruiting
Clinilabs
Eatontown, New Jersey 07724
United StatesActive - Recruiting
CenExel HRI
Marlton, New Jersey 08053
United StatesActive - Recruiting
New York State Psychiatric Institute
New York, New York 10032
United StatesSite Not Available
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