Your session is about to expire
← Back to Search
Alpha-2 Adrenergic Agonist
Intervention (protocolized clonidine initiation) for Substance Withdrawal
Phase 4
Waitlist Available
Led By Andrea Heifner, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during time in pediatric intensive care unit (about 5 to 7 days)
Awards & highlights
Study Summary
This trial tests if a drug can reduce symptoms, shorten hospital stays, and reduce costs for sedation in the hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during time in pediatric intensive care unit (about 5 to 7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during time in pediatric intensive care unit (about 5 to 7 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with withdrawal as indicated by score on the Withdrawal Assessment Tool (WAT)
Secondary outcome measures
Dexmedetomidine
Pediatric Intensive Care Unit (PICU) length of stay
Sedation costs
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (protocolized clonidine initiation)Experimental Treatment1 Intervention
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Group II: Usual care (without protocolized clonidine initiation)Active Control1 Intervention
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clonidine (protocolized initiation)
2022
Completed Phase 4
~130
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
912 Previous Clinical Trials
323,594 Total Patients Enrolled
Andrea Heifner, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of mental health issues.You are taking alpha-2 agonist medications at home.People who have died while taking dexmedetomidine.You have been receiving dexmedetomidine continuously for 3 or more days.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care (without protocolized clonidine initiation)
- Group 2: Intervention (protocolized clonidine initiation)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger