Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (MOMs-INO)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03911739|
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opiate Withdrawal Syndrome Drug Abuse in Pregnancy||Drug: Buprenorphine Injection Drug: Buprenorphine Sublingual Product||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Other Name: CAM2038
Active Comparator: BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
- Bayley Scales of Infant Development [ Time Frame: 24 months post-partum ]The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
- Bayley Scales of Infant Development [ Time Frame: 12 months post-partum ]The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
- Child Behavior Checklist [ Time Frame: 24 months post-partum ]The Child Behavior Checklist includes items that describe behavioral, emotional, and social problems that characterize preschool children.
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): NCT03911739
|Contact: Frankie Kropp, MSfirstname.lastname@example.org|
|Contact: Ben Kropp, MSLSemail@example.com|
|United States, California|
|Zuckerberg San Francisco General|
|San Francisco, California, United States, 94110|
|United States, Florida|
|Gateway Community Services|
|Jacksonville, Florida, United States, 32204|
|United States, Kentucky|
|University of Kentucky Center on Drug and Alcohol Research (CDAR)|
|Lexington, Kentucky, United States, 40502|
|United States, Massachusetts|
|Massachusetts General Hospital HOPE Clinic|
|Boston, Massachusetts, United States, 02114|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, New Mexico|
|University of New Mexico Milagro Clinic|
|Albuquerque, New Mexico, United States, 87106|
|United States, Oregon|
|Portland, Oregon, United States, 97214|
|United States, Pennsylvania|
|Pregnancy Recovery Center at Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|University of Utah SUPeRAD Clinic|
|Salt Lake City, Utah, United States, 84108|
|United States, Washington|
|Addiction Recovery Services (ARS), Swedish Medical Center|
|Seattle, Washington, United States, 98107|
|Principal Investigator:||Theresa Winhusen, PhD||University of Cincinnati|