Trial · NCT01360450
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
NCT01360450, Phase 2, Phase 3, Terminated, Johns Hopkins University; results first posted 2017-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants. Trials, record NCT01360450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
- NCT number
- NCT01360450
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Clonidine HCL, saline
- First posted
- 2011-05-25
- Last updated
- 2017-09-13
- Results first posted
- 2017-09-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Complete Detoxification | up to 4 weeks | Time to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of \<9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal. |
| Secondary | Cardiovascular Side-effects Changes HR and BP | 48 hrs after starting study drug and for 48hrs after stopping study drug | Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug |
| Secondary | Cumulative Dose of Opioid and Benzodiazepine | 2-4 weeks | We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Complete Detoxification | up to 4 weeks | days | MEAN | |
| SECONDARY | Cardiovascular Side-effects Changes HR and BP | 48 hrs after starting study drug and for 48hrs after stopping study drug | No data is available for this outcome measure, as it was not collected. | ||
| SECONDARY | Cumulative Dose of Opioid and Benzodiazepine | 2-4 weeks | No data is available for this outcome measure, as it was not collected. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Complete Detoxification | Treatment | total days on narcotics | 89.5 | Standard Deviation 137 | days |
| Time to Complete Detoxification | Control | total days on narcotics | 37.2 | Standard Deviation 10 | days |
| Time to Complete Detoxification | Treatment | duration on study drug in days | 21 | Standard Deviation 18.1 | days |
| Time to Complete Detoxification | Control | duration on study drug in days | 14.2 | Standard Deviation 8.5 | days |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 6 | |
| Overall Study | STARTED | Control | 6 | |
| Overall Study | Completed Treatment | Treatment | 6 | |
| Overall Study | Completed Treatment | Control | 6 | |
| Overall Study | COMPLETED | Treatment | 6 | |
| Overall Study | COMPLETED | Control | 6 | |
| Overall Study | NOT COMPLETED | Treatment | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 6 |
| Total, all-cause mortality | Control | 0 | 6 |
| Total, other adverse events | Treatment | 0 | 6 |
| Total, other adverse events | Control | 0 | 6 |
| Total, serious adverse events | Treatment | 0 | 6 |
| Total, serious adverse events | Control | 0 | 6 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DA029295 | Efficacy of clonidine in reducing iatrogenic-induced opioid dependence in infants | GAUDA, ESTELLE B. | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2010 to 2011 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Control: deaths from any cause | Trial comparisons |
| Treatment vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01360450
GET https://conductscience.org/api/trials/v1/NCT01360450/registered