Neonatal Abstinence SyndromePhase 2NASNCT00510016
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
A Phase 2 study testing Clonidine HCL in people with Neonatal Abstinence Syndrome, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Clonidine HCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- < 35 weeks gestational age
- Intrauterine growth retardation defined as <5%tile of gestational age
- postnatal treatment with barbiturates or benzodiazepines,
- major congenital anomalies
- major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
- breastfed infants
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287-3200
About this study
Official title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Clonidine HCL
- Keywords
- infants, opioid withdrawal, abstinence syndrome, methadone, heroin
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine HCLDrug
Also called Duraclon
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
| Study group | Role | What they receive |
|---|---|---|
| Clonidine treatment | Experimental | Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart. Receives: Drug: Clonidine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of treatment for neonatal abstinence syndrome
Measured: duration of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJul 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Investigators
- Estelle B Gauda, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510016
- Sponsor's protocol ID
- 1R21DA016288-01A1
- Other IDs
- 1R21DA016288-01A1
- Acronym
- NAS
- Status last verified
- Jul 2007
- First submitted
- 31 Jul 2007
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51. doi: 10.1016/0165-1781(84)90039-8.
PubMed 6597462Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available.
PubMed 6107698Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.
PubMed 19398463
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00510016
- Acronym / sponsor ID
- NAS / 1R21DA016288-01A1
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- infants, opioid withdrawal, abstinence syndrome, methadone, heroin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- Jul 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonidine treatment | Experimental | Drug: Clonidine HCLInfants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- < 35 weeks gestational age
- Intrauterine growth retardation defined as <5%tile of gestational age
- postnatal treatment with barbiturates or benzodiazepines,
- major congenital anomalies
- major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
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 HCLAlso: DuraclonDuraclon 1 microgram/kg every 4 hours given p.o. as per algorithm | Drug | Clonidine treatment |
Primary outcome
Length of treatment for neonatal abstinence syndrome
Time frame: duration of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 6597462Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51. doi: 10.1016/0165-1781(84)90039-8.
- Background: PubMed 6107698Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available.
- Derived from this study: PubMed 19398463Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.
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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.
Estelle B Gauda, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine HCL in people with Neonatal Abstinence Syndrome, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 0 inclusion and 6 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 11 Jan 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of treatment for neonatal abstinence syndrome (time frame: duration of the treatment). 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 NCT00510016, which also lists 3 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 11 Jan 2017.