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Dexmedetomidine · 1 trial · 1 indication
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...
Dexmedetomidine is being studied for the treatment of symptoms of acute opioid withdrawal. It is an investigational small molecule in Phase 1 clinical development for this indication. The drug is being developed by BioXcel Therapeutics, Inc. (BTAI) as a potential treatment option for patients experiencing opioid withdrawal.
BioXcel Therapeutics, Inc. (BTAI) is developing Dexmedetomidine for opioid withdrawal. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating symptoms of acute opioid withdrawal. Dexmedetomidine is currently in Phase 1 clinical development for this indication.
Dexmedetomidine is in Phase 1 clinical development for opioid withdrawal. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials. A Phase 1 trial has been completed to evaluate its effects on symptoms of acute opioid withdrawal.
Dexmedetomidine has been studied in a completed Phase 1 clinical trial with the identifier NCT04470050. The trial, titled 'Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal,' enrolled 225 participants in the United States. The study was randomized, double-blind, and controlled, and included adults aged 18 years and older.
Dexmedetomidine is a distinct investigational drug being developed by BioXcel Therapeutics, Inc. for opioid withdrawal. It is a small molecule in Phase 1 clinical development. No alternative names have been established for this drug in the context of its development for opioid withdrawal.