Trial · NCT00271219

RCT Comparing Methadone and Buprenorphine in Pregnant Women

NCT00271219, Phase 3, Completed, Johns Hopkins University; results first posted 2015-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RCT Comparing Methadone and Buprenorphine in Pregnant Women. Trials, record NCT00271219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00271219

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RCT Comparing Methadone and Buprenorphine in Pregnant Women
NCT number: NCT00271219
Status: Completed
Phases: Phase 3
Enrollment: 175 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Opioid Related Disorders, Pregnancy, Opioid Dependence
Interventions: Methadone, Buprenorphine
First posted: 2005-12-30
Last updated: 2015-08-05
Results first posted: 2015-08-05

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Child's Head Circumference Measurement (Measured at Birth)	birth
Primary	Child's Length of Hospital Stay	delivery until hospital discharge (min=2 days, max=79 days)
Primary	Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)	From birth until hospital discharge (min=4 days, max=10, depending on site)	Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.
Primary	Child's Peak Daily Total NAS Score	minimum twice daily from birth until NAS no longer measured (min=10 days)	NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.
Primary	Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS	Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)	Total amount in mg
Secondary	Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)	monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
Secondary	Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)	monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)
Secondary	Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)	from study entry until discontinuation or delivery (min=29 days, max=239 days)	Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.
Secondary	Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score	at delivery	The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Child's Head Circumference Measurement (Measured at Birth)	birth		cm	MEAN
PRIMARY	Child's Length of Hospital Stay	delivery until hospital discharge (min=2 days, max=79 days)		days	MEAN
PRIMARY	Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)	From birth until hospital discharge (min=4 days, max=10, depending on site)		participants	NUMBER
PRIMARY	Child's Peak Daily Total NAS Score	minimum twice daily from birth until NAS no longer measured (min=10 days)		Score on the scale	MEAN
PRIMARY	Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS	Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)		mg	MEAN
SECONDARY	Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)	monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)	frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy	percentage of drug use	NUMBER
SECONDARY	Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)	monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)	frequency of occurrence too low to be estimated with accuracy	percentage of HIV risk behaviors	NUMBER
SECONDARY	Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)	from study entry until discontinuation or delivery (min=29 days, max=239 days)	intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy	dose increase per trimester	NUMBER
SECONDARY	Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score	at delivery		Score on the scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Child's Head Circumference Measurement (Measured at Birth)	A Methadone	33.0	95% Confidence Interval 32.7 to 33.3	cm
Child's Head Circumference Measurement (Measured at Birth)	B Buprenorphine	33.8	95% Confidence Interval 33.5 to 34.1	cm
Child's Length of Hospital Stay	A Methadone	17.5	95% Confidence Interval 16 to 19	days
Child's Length of Hospital Stay	B Buprenorphine	10.0	95% Confidence Interval 8.8 to 11.2	days
Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)	A Methadone	41		participants
Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)	B Buprenorphine	27		participants
Child's Peak Daily Total NAS Score	A Methadone	12.8	95% Confidence Interval 12.2 to 13.4	Score on the scale
Child's Peak Daily Total NAS Score	B Buprenorphine	11.0	95% Confidence Interval 10.4 to 11.6	Score on the scale
Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS	A Methadone	10.4	95% Confidence Interval 7.8 to 13	mg
Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS	B Buprenorphine	1.1	95% Confidence Interval 0.4 to 1.8	mg

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Methadone	89
Overall Study	STARTED	Buprenorphine	86
Overall Study	COMPLETED	Methadone	73
Overall Study	COMPLETED	Buprenorphine	58
Overall Study	NOT COMPLETED	Methadone	16
Overall Study	NOT COMPLETED	Buprenorphine	28

Source ClinicalTrials.gov

Adverse events168

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abnormal fetal health	Pregnancy, puerperium and perinatal conditions	Methadone: Mothers	6	89
other	Abnormal fetal health	Pregnancy, puerperium and perinatal conditions	Buprenorphine: Mothers	4	86
other	Abnormal fetal health	Pregnancy, puerperium and perinatal conditions	Methadone: Neonates	0	0
other	Abnormal fetal health	Pregnancy, puerperium and perinatal conditions	Buprenorphine: Neonates	0	0
other	abnormal appetite	Gastrointestinal disorders	Methadone: Mothers	2	89
other	abnormal appetite	Gastrointestinal disorders	Buprenorphine: Mothers	0	86
other	abnormal appetite	Gastrointestinal disorders	Methadone: Neonates	4	73
other	abnormal appetite	Gastrointestinal disorders	Buprenorphine: Neonates	1	58
other	abnormal laboratory values	General disorders	Methadone: Mothers	10	89
other	abnormal laboratory values	General disorders	Buprenorphine: Mothers	8	86

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Methadone: Mothers
Total, all-cause mortality	Buprenorphine: Mothers
Total, all-cause mortality	Methadone: Neonates
Total, all-cause mortality	Buprenorphine: Neonates
Total, other adverse events	Methadone: Mothers	83	89
Total, other adverse events	Buprenorphine: Mothers	66	86
Total, other adverse events	Methadone: Neonates	34	73
Total, other adverse events	Buprenorphine: Neonates	29	58
Total, serious adverse events	Methadone: Mothers	14	89
Total, serious adverse events	Buprenorphine: Mothers	8	86

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21142534	DERIVED	PubMed
22088886	DERIVED	PubMed
23106923	DERIVED	PubMed
23106924	DERIVED	PubMed
23106925	DERIVED	PubMed
23106926	DERIVED	PubMed
23106927	DERIVED	PubMed
23106928	DERIVED	PubMed
23106929	DERIVED	PubMed
23106930	DERIVED	PubMed

1 to 10 of 14

See all 14 papers

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
R01DA015764	Maternal Opioid Treatment: Human Experimental Research	JONES, HENDREE E	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2004 to 2008

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
A Methadone vs B Buprenorphine: Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00271219

GET https://conductscience.org/api/trials/v1/NCT00271219/events?page=2

API reference For AI assistants