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Alpha-2 Agonist

Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (RELEASE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by BioXcel Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose

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.

Eligible Conditions
  • Opioid Withdrawal Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Peak SOWS Scores at Baseline and Over Time
Secondary study objectives
Average COWS Scores at Baseline and Over Time
Average SOWS at Baseline and Over Time
Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 6- Dexmedetomidine (240 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 240 Micrograms Dexmedetomidine or Placebo Sublingual film
Group II: Cohort 5- Dexmedetomidine (180 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 180 Micrograms Dexmedetomidine or Placebo Sublingual film
Group III: Cohort 4- Dexmedetomidine (120 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 120 Micrograms Dexmedetomidine or Placebo Sublingual film
Group IV: Cohort 3- Dexmedetomidine (90 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 90 Micrograms Dexmedetomidine or Placebo Sublingual film
Group V: Cohort 2- Dexmedetomidine (60 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 60 Micrograms Dexmedetomidine or Placebo Sublingual film
Group VI: Cohort 1- Dexmedetomidine (30 Micrograms) vs. PlaceboExperimental Treatment2 Interventions
Sublingual film containing 30 Micrograms Dexmedetomidine or Placebo Sublingual film
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~2050
Placebo
1995
Completed Phase 3
~2670

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Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
2,130 Total Patients Enrolled
Cognitive Research CorporationIndustry Sponsor
24 Previous Clinical Trials
2,163 Total Patients Enrolled
Robert Risinger, MDStudy DirectorChief Medical Officer
10 Previous Clinical Trials
1,600 Total Patients Enrolled
~41 spots leftby Dec 2025
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