Phase 3
N=175
RCT Comparing Methadone and Buprenorphine in Pregnant Women
Opioid Related Disorders · Pregnancy · Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00271219 ↗Enrolled (actual)
175
Serious AEs
9.5%
Results posted
Aug 2015
Primary outcome: Primary: Child's Head Circumference Measurement (Measured at Birth) — 33.0; 33.8 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methadone (Drug); Buprenorphine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child's Head Circumference Measurement (Measured at Birth) |
33.0; 33.8 | — |
| PRIMARY Child's Length of Hospital Stay |
17.5; 10.0 | — |
| PRIMARY Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) |
41; 27 | — |
| PRIMARY Child's Peak Daily Total NAS Score |
12.8; 11.0 | — |
| PRIMARY Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS |
10.4; 1.1 | — |
| SECONDARY Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back) |
NA; NA | — |
| SECONDARY Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment) |
NA; NA | — |
| SECONDARY Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure) |
NA; NA | — |
| SECONDARY Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score |
.014; .088 | — |
Summary
Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.
Eligibility Criteria
Inclusion Criteria
- Current opioid dependence
- Current opioid use, as determined by a urine drug test
- Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined by a sonogram
Exclusion Criteria
- Current medical condition that would make study participation dangerous, as determined by study physician
- Diagnosed with an acute, severe psychiatric illness
- Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse
- Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined by the Addiction Severity Index
- Pending legal action that may prohibit or interfere with study participation
Data sourced from ClinicalTrials.gov (NCT00271219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.