Withdrawal; Therapeutic SubstancePhase 4NCT05575219

Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal

A Phase 4 study testing Clonidine (without protocolized initiation) and Clonidine (protocolized initiation) in people with Withdrawal; Therapeutic Substance, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine if the protocolized use of clonidine will reduce dexmedetomidine withdrawal symptoms, reduce PICU length of stay, and reduce costs related to sedation during hospital admission. Read more about this study

Who is it for?: Ages 4 weeks to 18 years
Conditions the study is for: Withdrawal; Therapeutic Substance
What is being tested?: Clonidine (without protocolized initiation) and Clonidine (protocolized initiation)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteUnited States
Study dates: 8 Oct 2022to 15 Feb 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 weeks to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Dexmedetomidine infusion for greater than or equal to 72 hours

Who cannot join

Admission for head trauma
Psychiatric history
Use of alpha-2 agonist medications at home
Death while on dexmedetomidine

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Memorial Hermann Hospital
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study

Conditions: Withdrawal; Therapeutic Substance
Being tested: Clonidine (without protocolized initiation), Clonidine (protocolized initiation)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clonidine (without protocolized initiation)Drug
Also called Clondine
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (protocolized initiation)Drug
Also called Clondine
- Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
- Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
- Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
- Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of >/= 168 hours or with infusion time of 120-167 hours at doses >/= 1.1 mcg/kg/min.
- If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).

Study groups in NCT05575219
Study group	Role	What they receive
Usual care (without protocolized clonidine initiation)	Active comparator	Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion. Receives: Drug: Clonidine (without protocolized initiation)
Intervention (protocolized clonidine initiation)	Experimental	A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine. Receives: Drug: Clonidine (protocolized initiation)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Withdrawal
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued.
WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal.
The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
Measured: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)

Secondary outcomes (4)

Hours on Dexmedetomidine
number of total hours on dexmedetomidine
Measured: During time in Pediatric Intensive Care Unit (about 260 Hours)
Pediatric Intensive Care Unit (PICU) Length of Stay
number of days in the PICU
Measured: During time in Pediatric Intensive Care Unit (about 10 to 30 days)
Dexmedetomidine Cost Per Kilogram During Hospitalization
Measured: During time in Pediatric Intensive Care Unit (about 24 days)
Clonidine Cost Per Kilogram During Hospitalization
Measured: During time in Pediatric Intensive Care Unit (about 24 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202215 Feb 2024

First posted12 Oct 2022
Study start8 Oct 2022
Primary completion15 Feb 2024
Study completion15 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Withdrawal; Therapeutic SubstanceStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05575219
Sponsor's protocol ID: HSC-MS-22-0410
Status last verified: Jan 2025
First submitted: 5 Oct 2022
Last updated: 28 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Berkenbosch JW. Dexmedetomidine and pediatric (cardiac) critical care--are we there yet? Pediatr Crit Care Med. 2010 Jan;11(1):148-9. doi: 10.1097/PCC.0b013e3181bc57c0. No abstract available.
PubMed 20051795
Berrens ZJ, Sauro AL, Tillman EM. Prevention of Withdrawal in Pediatric Patients Receiving Long-term Dexmedetomidine Infusions. J Pediatr Pharmacol Ther. 2021;26(1):81-86. doi: 10.5863/1551-6776-26.1.81. Epub 2021 Jan 4.
PubMed 33424504
Bhatt K, Thompson Quan A, Baumgartner L, Jia S, Croci R, Puntillo K, Ramsay J, Bouajram RH. Effects of a Clonidine Taper on Dexmedetomidine Use and Withdrawal in Adult Critically Ill Patients-A Pilot Study. Crit Care Explor. 2020 Nov 3;2(11):e0245. doi: 10.1097/CCE.0000000000000245. eCollection 2020 Nov.
PubMed 33163969
Curley MA, Harris SK, Fraser KA, Johnson RA, Arnold JH. State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006 Mar;7(2):107-14. doi: 10.1097/01.PCC.0000200955.40962.38.
PubMed 16446601
Darnell C, Steiner J, Szmuk P, Sheeran P. Withdrawal from multiple sedative agent therapy in an infant: is dexmedetomidine the cause or the cure? Pediatr Crit Care Med. 2010 Jan;11(1):e1-3. doi: 10.1097/PCC.0b013e3181a66131.
PubMed 20051785
Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
PubMed 18838937
Franck LS, Scoppettuolo LA, Wypij D, Curley MAQ. Validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) for monitoring iatrogenic withdrawal syndrome in pediatric patients. Pain. 2012 Jan;153(1):142-148. doi: 10.1016/j.pain.2011.10.003. Epub 2011 Nov 16.
PubMed 22093817
Haenecour AS, Seto W, Urbain CM, Stephens D, Laussen PC, Balit CR. Prolonged Dexmedetomidine Infusion and Drug Withdrawal In Critically Ill Children. J Pediatr Pharmacol Ther. 2017 Nov-Dec;22(6):453-460. doi: 10.5863/1551-6776-22.6.453.
PubMed 29290746
Lardieri AB, Fusco NM, Simone S, Walker LK, Morgan JA, Parbuoni KA. Effects of Clonidine on Withdrawal From Long-term Dexmedetomidine in the Pediatric Patient. J Pediatr Pharmacol Ther. 2015 Jan-Feb;20(1):45-53. doi: 10.5863/1551-6776-20.1.45.
PubMed 25859170
Liu J, Miller J, Ferguson M, Bagwell S, Bourque J. The Impact of a Clonidine Transition Protocol on Dexmedetomidine Withdrawal in Critically Ill Pediatric Patients. J Pediatr Pharmacol Ther. 2020;25(4):278-287. doi: 10.5863/1551-6776-25.4.278.
PubMed 32461740
Nguyen TL, Lam WM, Orr H, Gulbis B, Mauricio R, Tom E, Modem VM, Coronado-Munoz A. Clonidine for the Treatment of Agitation After Dexmedetomidine Discontinuation in Pediatric Patients: A Retrospective Cohort Study. J Pediatr Pharmacol Ther. 2021;26(8):821-827. doi: 10.5863/1551-6776-26.8.821. Epub 2021 Nov 10.
PubMed 34790072
Shutes BL, Gee SW, Sargel CL, Fink KA, Tobias JD. Dexmedetomidine as Single Continuous Sedative During Noninvasive Ventilation: Typical Usage, Hemodynamic Effects, and Withdrawal. Pediatr Crit Care Med. 2018 Apr;19(4):287-297. doi: 10.1097/PCC.0000000000001451.
PubMed 29341985
Thompson RZ, Gardner BM, Autry EB, Day SB, Krishna AS. Survey of the Current Use of Dexmedetomidine and Management of Withdrawal Symptoms in Critically Ill Children. J Pediatr Pharmacol Ther. 2019 Jan-Feb;24(1):16-21. doi: 10.5863/1551-6776-24.1.16.
PubMed 30837809
Traube C, Silver G, Kearney J, Patel A, Atkinson TM, Yoon MJ, Halpert S, Augenstein J, Sickles LE, Li C, Greenwald B. Cornell Assessment of Pediatric Delirium: a valid, rapid, observational tool for screening delirium in the PICU*. Crit Care Med. 2014 Mar;42(3):656-63. doi: 10.1097/CCM.0b013e3182a66b76.
PubMed 24145848
Weber MD, Thammasitboon S, Rosen DA. Acute discontinuation syndrome from dexmedetomidine after protracted use in a pediatric patient. Paediatr Anaesth. 2008 Jan;18(1):87-8. doi: 10.1111/j.1460-9592.2007.02377.x. No abstract available.
PubMed 18095980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruitingPhase 1/2
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
Opioid Use Disorder, Opioid Withdrawal
Not yet recruitingPhase 2
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
Alcohol Use Disorder

All Withdrawal; Therapeutic Substance trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study
ClinicalTrials.gov ID: NCT05575219
Acronym / sponsor ID: HSC-MS-22-0410
Conditions: Withdrawal; Therapeutic Substance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 8 Oct 2022 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 15 Feb 2024 (actual)
First posted: 12 Oct 2022 (actual)
Results: Posted 28 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual care (without protocolized clonidine initiation)	Active comparator	Drug: Clonidine (without protocolized initiation)Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Intervention (protocolized clonidine initiation)	Experimental	Drug: Clonidine (protocolized initiation)A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.

Who may qualify

Ages: 4 weeks to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Dexmedetomidine infusion for greater than or equal to 72 hours

Key exclusion criteria (4 listed)

Admission for head trauma
Psychiatric history
Use of alpha-2 agonist medications at home
Death while on dexmedetomidine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clonidine (without protocolized initiation)Also: ClondineParticipants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.	Drug	Usual care (without protocolized clonidine initiation)
Clonidine (protocolized initiation)Also: Clondine* Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours. * Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours. * Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours. * Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of >/= 168 hours or with infusion time of 120-167 hours at doses >/= 1.1 mcg/kg/min. * If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).	Drug	Intervention (protocolized clonidine initiation)

Primary outcome

Number of Participants With Withdrawal
Time frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued. WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal. The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.

4 secondary outcomes

Hours on Dexmedetomidine
Time frame: During time in Pediatric Intensive Care Unit (about 260 Hours)
Pediatric Intensive Care Unit (PICU) Length of Stay
Time frame: During time in Pediatric Intensive Care Unit (about 10 to 30 days)
Dexmedetomidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)
Clonidine Cost Per Kilogram During Hospitalization
Time frame: During time in Pediatric Intensive Care Unit (about 24 days)

Results and safety

Results posted to the registry on 28 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care (Without Protocolized Clonidine Initiation)	96	96
Intervention (Protocolized Clonidine Initiation)	32	32

Primary outcome: Number of Participants With Withdrawal

Time frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days). Count of participants. Unit: Participants

Measure	Usual Care (Without Protocolized Clonidine Initiation) n = 91	Intervention (Protocolized Clonidine Initiation) n = 30
Value	33	10

Population analysed: Data were not collected from 5 participants in the Usual care (without protocolized clonidine initiation) arm. Data were not collected from 2 participants in the Intervention (protocolized clonidine initiation) arm.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to time in PICU (about 24 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care (Without Protocolized Clonidine Initiation)	0 of 96 (0%)	0 of 96 (0%)	0 of 96
Intervention (Protocolized Clonidine Initiation)	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20051795Berkenbosch JW. Dexmedetomidine and pediatric (cardiac) critical care--are we there yet? Pediatr Crit Care Med. 2010 Jan;11(1):148-9. doi: 10.1097/PCC.0b013e3181bc57c0. No abstract available.
Background: PubMed 33424504Berrens ZJ, Sauro AL, Tillman EM. Prevention of Withdrawal in Pediatric Patients Receiving Long-term Dexmedetomidine Infusions. J Pediatr Pharmacol Ther. 2021;26(1):81-86. doi: 10.5863/1551-6776-26.1.81. Epub 2021 Jan 4.
Background: PubMed 33163969Bhatt K, Thompson Quan A, Baumgartner L, Jia S, Croci R, Puntillo K, Ramsay J, Bouajram RH. Effects of a Clonidine Taper on Dexmedetomidine Use and Withdrawal in Adult Critically Ill Patients-A Pilot Study. Crit Care Explor. 2020 Nov 3;2(11):e0245. doi: 10.1097/CCE.0000000000000245. eCollection 2020 Nov.
Background: PubMed 16446601Curley MA, Harris SK, Fraser KA, Johnson RA, Arnold JH. State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006 Mar;7(2):107-14. doi: 10.1097/01.PCC.0000200955.40962.38.
Background: PubMed 20051785Darnell C, Steiner J, Szmuk P, Sheeran P. Withdrawal from multiple sedative agent therapy in an infant: is dexmedetomidine the cause or the cure? Pediatr Crit Care Med. 2010 Jan;11(1):e1-3. doi: 10.1097/PCC.0b013e3181a66131.
Background: PubMed 18838937Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
Background: PubMed 22093817Franck LS, Scoppettuolo LA, Wypij D, Curley MAQ. Validity and generalizability of the Withdrawal Assessment Tool-1 (WAT-1) for monitoring iatrogenic withdrawal syndrome in pediatric patients. Pain. 2012 Jan;153(1):142-148. doi: 10.1016/j.pain.2011.10.003. Epub 2011 Nov 16.
Background: PubMed 29290746Haenecour AS, Seto W, Urbain CM, Stephens D, Laussen PC, Balit CR. Prolonged Dexmedetomidine Infusion and Drug Withdrawal In Critically Ill Children. J Pediatr Pharmacol Ther. 2017 Nov-Dec;22(6):453-460. doi: 10.5863/1551-6776-22.6.453.
Background: PubMed 25859170Lardieri AB, Fusco NM, Simone S, Walker LK, Morgan JA, Parbuoni KA. Effects of Clonidine on Withdrawal From Long-term Dexmedetomidine in the Pediatric Patient. J Pediatr Pharmacol Ther. 2015 Jan-Feb;20(1):45-53. doi: 10.5863/1551-6776-20.1.45.
Background: PubMed 32461740Liu J, Miller J, Ferguson M, Bagwell S, Bourque J. The Impact of a Clonidine Transition Protocol on Dexmedetomidine Withdrawal in Critically Ill Pediatric Patients. J Pediatr Pharmacol Ther. 2020;25(4):278-287. doi: 10.5863/1551-6776-25.4.278.
Background: PubMed 34790072Nguyen TL, Lam WM, Orr H, Gulbis B, Mauricio R, Tom E, Modem VM, Coronado-Munoz A. Clonidine for the Treatment of Agitation After Dexmedetomidine Discontinuation in Pediatric Patients: A Retrospective Cohort Study. J Pediatr Pharmacol Ther. 2021;26(8):821-827. doi: 10.5863/1551-6776-26.8.821. Epub 2021 Nov 10.
Background: PubMed 29341985Shutes BL, Gee SW, Sargel CL, Fink KA, Tobias JD. Dexmedetomidine as Single Continuous Sedative During Noninvasive Ventilation: Typical Usage, Hemodynamic Effects, and Withdrawal. Pediatr Crit Care Med. 2018 Apr;19(4):287-297. doi: 10.1097/PCC.0000000000001451.
Individual participant dataSharing planned: No

Related trials for Withdrawal; Therapeutic Substance

Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruitingPhase 1/2
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
Opioid Use Disorder, Opioid Withdrawal
Not yet recruitingPhase 2
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
Alcohol Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea Heifner, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Withdrawal (time frame: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575219, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.