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RCT Comparing Methadone and Buprenorphine in Pregnant Women

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00271219
First received: December 28, 2005
Last updated: July 30, 2015
Last verified: July 2015
Results First Received: March 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Opioid Related Disorders
Pregnancy
Opioid Dependence
Interventions: Drug: Methadone
Drug: Buprenorphine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1074 Patients were screened for eligibility. 175 underwent randomization. 86 were assigned to receive buprenorphine. 58 of the patients assigned to buprenorphine completed the study. 89 were assigned to receive methadone. 73 of the patients assigned to methadone completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1074 screened: 243 did not give consent. 656 were excluded for a variety of reasons ranging from an estimated gestation age outside the range, to impending legal issues, to multiple-fetus pregnancy.

Reporting Groups
  Description
Methadone

Methadone

Methadone : daily oral dosing 20-140 mg

Buprenorphine

Buprenorphine

Buprenorphine : sl daily 2-32 mg


Participant Flow:   Overall Study
    Methadone   Buprenorphine
STARTED   89   86 
COMPLETED   73   58 
NOT COMPLETED   16   28 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Methadone

Methadone

Methadone : daily oral dosing 20-140 mg

Buprenorphine

Buprenorphine

Buprenorphine : sl daily 2-32 mg

Total Total of all reporting groups

Baseline Measures
   Methadone   Buprenorphine   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   58   131 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   73   58   131 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.7  (0.7)   25.3  (0.7)   26.5  (0.7) 
Gender 
[Units: Participants]
     
Female   73   58   131 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   54   40   94 
Austria   19   18   37 


  Outcome Measures
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1.  Primary:   Child's Head Circumference Measurement (Measured at Birth)   [ Time Frame: birth ]

2.  Primary:   Child's Length of Hospital Stay   [ Time Frame: delivery until hospital discharge (min=2 days, max=79 days) ]

3.  Primary:   Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)   [ Time Frame: From birth until hospital discharge (min=4 days, max=10, depending on site) ]

4.  Primary:   Child's Peak Daily Total NAS Score   [ Time Frame: minimum twice daily from birth until NAS no longer measured (min=10 days) ]

5.  Primary:   Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS   [ Time Frame: Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days) ]

6.  Secondary:   Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)   [ Time Frame: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days) ]

7.  Secondary:   Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)   [ Time Frame: monthly from study entry until discontinuation or delivery (min=29 days, max=239 days) ]

8.  Secondary:   Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)   [ Time Frame: from study entry until discontinuation or delivery (min=29 days, max=239 days) ]

9.  Secondary:   Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score   [ Time Frame: at delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hendree Jones
Organization: Departments of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology, Johns Hopkins University School of Medicine
phone: 919-485-2664
e-mail: hjones18@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Hendree E. Jones, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00271219     History of Changes
Other Study ID Numbers: R01DA15764-1
R01DA015764 ( US NIH Grant/Contract Award Number )
DPMC
Study First Received: December 28, 2005
Results First Received: March 11, 2013
Last Updated: July 30, 2015
Health Authority: United States: Food and Drug Administration