Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (NCT04470050) | Clinical Trial Compass
CompletedPhase 1/2
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
United States225 participantsStarted 2020-06-09
Plain-language summary
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo phase (Phase 2) included Days 6-12. The randomized phase was followed by 2 sequential days, Days 13 and 14, utilizing treatment of BXCL501-placebo sublingual films and morphine-placebo capsules for all subjects who remained in the study.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female subjects who are 18 years of age to less than 65 years of age.
✓. Meets criteria for moderate to severe opioid use disorder as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and 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 admission on Day 1.
✓. Subjects who can read, understand, and provide written informed consent. Women of childbearing potential must have a negative pregnancy test and agree to be abstinent or use an acceptable method of contraception for the duration of the study.
Exclusion criteria
✕. Positive urine pregnancy test at screening or when tested or currently breast feeding.
✕. Clinically significant history of cardiac disease, screening and baseline heart rate of \<55 beats per minutes or systolic blood pressure \<110 mmHg or diastolic blood pressure \<70 mmHg.
✕. History or presence of a significant medical disease or disorder which, in the opinion of the investigator, increases the risk or may confound the interpretation of study measures, as confirmed by screening laboratory results.
✕. Hepatic dysfunction (marked by ascites, or bilirubin \>10% above the upper limit of normal \[ULN\] or liver function tests \>3 x ULN) at the screening visit.
✕. Acute active Hepatitis B or C as evidenced by positive serology and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>2 x ULN.
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What they're measuring
1
Peak SOWS Scores at Baseline and Over Time
Timeframe: Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose
. Clinically significant abnormal ECG findings such as second- or third-degree heart block, uncontrolled arrhythmia, or QTcF (Fridericia correction formula) interval \>450 msec for males, and \>470 msec for females at screening or prior to dosing.
✕. Any psychiatric disorder that would compromise ability to complete study requirements.
✕. Currently meets DSM-5 criteria for substance abuse disorder, moderate or severe for any substance other than opioids, caffeine, or nicotine and/or current physical dependence on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines.