Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04470050 | Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal | PHASE1 | COMPLETED | 225 | — | — | Jun 9, 2020 | Feb 18, 2021 | Jun 3, 2026 | 3 | United States |
Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms.
| Arm | Type | Description |
|---|---|---|
| Cohort 1- Dexmedetomidine (30 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 30 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Cohort 2- Dexmedetomidine (60 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Cohort 3- Dexmedetomidine (90 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 90 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Cohort 4- Dexmedetomidine (120 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Cohort 5- Dexmedetomidine (180 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 180 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Cohort 6- Dexmedetomidine (240 Micrograms) vs. Placebo | EXPERIMENTAL | Sublingual film containing 240 Micrograms Dexmedetomidine or Placebo Sublingual film |
| Name | Type | Description |
|---|---|---|
| Dexmedetomidine | DRUG | Sublingual Film of Dexmedetomidine |
| Placebo | DRUG | Sublingual Placebo film |
Inclusion Criteria 1. Male and female subjects who are 18 years of age to less than 65 years of age. 2. 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 Neur...