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Alpha-2 Adrenergic Agonist

Sublingual Dexmedetomidine for Opioid Withdrawal

Phase 1 & 2
Recruiting
Led By Sandra Comer, Ph.D
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of understanding and complying with the protocol.
Aged 18 to 60 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study days 1-7
Awards & highlights

Study Summary

This trial will study a new non-opioid medication to ease opioid withdrawal symptoms like anxiety, nausea, and insomnia. It will compare safety and efficacy against a current non-opioid and placebo in OUD patients.

Who is the study for?
This trial is for adults aged 18-60 with moderate-to-severe opioid use disorder who are physically dependent on opioids. Participants must understand the study and agree to contraception if applicable. Exclusions include methadone or buprenorphine in urine, pregnancy, significant medical conditions, abnormal ECGs, liver issues, recent naltrexone use, certain medication uses that affect safety or trial outcomes, psychiatric disorders affecting study compliance, alcohol/benzodiazepine detox need, recent other clinical trial participation and specific cardiac history.Check my eligibility
What is being tested?
The trial tests BXCL501 (dexmedetomidine sublingual film) against lofexidine and a placebo to see which better reduces opioid withdrawal symptoms without severe side effects like low blood pressure. Over seven days inpatient treatment at three sites will compare their safety and efficacy in individuals withdrawing from opioids.See study design
What are the potential side effects?
Dexmedetomidine may cause sedation and pain relief with less impact on blood pressure than lofexidine but can still lead to potential side effects such as drowsiness or changes in heart rhythm. Lofexidine might cause sedation and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand and can follow the study's requirements.
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I am between 18 and 60 years old.
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I agree to use birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days 1-7
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1-7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events: BXCL501 versus Placebo and Lofexidine (Positive Control)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BXCL501 (240 micrograms)Experimental Treatment1 Intervention
The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo.
Group II: BXCL501 (180 micrograms)Experimental Treatment1 Intervention
The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo.
Group III: Lofexidine (Positive Control)Active Control1 Intervention
The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo.
Group IV: PlaceboPlacebo Group1 Intervention
The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,804 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,097 Total Patients Enrolled
BioXcel Therapeutics IncIndustry Sponsor
19 Previous Clinical Trials
2,272 Total Patients Enrolled

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05712707 — Phase 1 & 2
Opioid Use Disorder Research Study Groups: Lofexidine (Positive Control), BXCL501 (240 micrograms), BXCL501 (180 micrograms), Placebo
Opioid Use Disorder Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT05712707 — Phase 1 & 2
Dexmedetomidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712707 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation cater to adults above 18 years of age?

"Eligible participants must be of the age of majority or older, but not exceeding 60 years."

Answered by AI

Is there an opportunity for individuals to volunteer as participants in this medical experiment?

"According to clinicaltrials.gov, this current medical trial went live on February 28th 2023 and was last modified a month later on March 27th of the same year. The study is actively seeking participants for enrolment."

Answered by AI

Is it possible for me to join this research endeavor?

"This investigation seeks 160 eligible participants with opioid withdrawal syndrome between ages 18 and 60. Those wishing to apply must be capable of adhering to the study protocol, have a DSM-V diagnosis of moderate or severe opioid use disorder, demonstrate physiological dependence on opioids, and female applicants will need to agree upon using contraception for the duration of the trial."

Answered by AI

What is the current sample size of this research trial?

"Correct. According to the clinicaltrials.gov records, this medical trial opened on February 28th 2023 and is still recruiting patients as of March 27th 2023. A total of 160 people must be enrolled at one designated location for the study to proceed."

Answered by AI

Who else is applying?

What site did they apply to?
Clinilabs
What portion of applicants met pre-screening criteria?
Met criteria
~70 spots leftby Jan 2025