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Opioid Dependence Treatment Therapies in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098407
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elizabeth Krans, MD, University of Pittsburgh

Brief Summary:

The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women.

A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.


Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Pregnancy Drug: Buprenorphine Drug: Methadone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Other
Official Title: A Pilot Randomized Comparative Effectiveness Clinical Trial of Buprenorphine vs. Methadone for the Treatment of Opioid Dependence in Pregnancy.
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : October 9, 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Buprenorphine Maintenance Treatment
Buprenorphine Maintenance Treatment patients will receive instructions regarding a follow-up, outpatient appointment with the Pregnancy Recovery Center at Magee-Womens Hospital, which specializes in Opioid maintenance treatment for pregnant patients, for the next day following enrollment in the study for induction onto buprenorphine maintenance treatment.
Drug: Buprenorphine
This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.

Methadone Maintenance Treatment
Methadone Maintenance Treatment patients will be immediately admitted to Magee-Womens Hospital for an inpatient induction onto methadone maintenance treatment.
Drug: Methadone
This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.




Primary Outcome Measures :
  1. Number of participants who are recruited, enrolled, retained, and who complete the study. [ Time Frame: 12 Months ]
    evaluate a minimum of 9 OD pregnant women per month for possible participation and enrollment, randomize a minimum of 4 participants per month to office-based buprenorphine (PRC) or methadone treatment facility (NATP) for a total of 50 participants over a 12 month enrollment period, retain ≥ 80% of randomized participants until 12 weeks postpartum, and maintain < 5% of incomplete data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women 18+ years old, with a singleton pregnancy ≤ 28 weeks gestation confirmed by ultrasound, who meet Diagnostic and Statistical Manual-IV criteria for opioid dependence confirmed by urine drug screen (UDS), who are interested in opioid maintenance treatment and plan to receive prenatal care and deliver at Magee Womens Hospital (MWH) will be recruited.

Exclusion Criteria:

  • (1) active, current dependence on benzodiazepines or alcohol
  • (2) acute severe psychiatric condition in need of immediate treatment (e.g. suicidal ideations)
  • (3) pending or legal action that could prohibit or interfere with participation (e.g. incarceration)
  • (4) current, established treatment with methadone or buprenorphine. Exclusion criteria are based on the Substance Abuse and Mental Health Services Administration (SAMHSA) recommendations for office-based buprenorphine use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098407


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Elizabeth E Krans, MD, MSc University of Pittsburgh
Publications:

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Responsible Party: Elizabeth Krans, MD, Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03098407    
Other Study ID Numbers: PRO16020403
1K23DA038789-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents