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Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

NCT04470050 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2023-10-26

Study results available
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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.

Conditions

  • Opioid Withdrawal

Interventions

DRUG

Dexmedetomidine

Sublingual Film of Dexmedetomidine

DRUG

Placebo

Sublingual Placebo film

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2021-02-18
Completion
2021-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470050 on ClinicalTrials.gov