Clinical trial NCT03911466: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Official title: NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
Neonatal Abstinence Syndrome
Neonatal Opioid Withdrawal Syndrome
Drug Abuse in Pregnancy
Keywords: CTN-0080
clinical trials network
medication assisted treatment
pharmacokinetics
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2019-04-11
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.

It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).


Eligibility criteria: Inclusion Criteria:

* Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Exclusion Criteria:

-

Primary outcomes:
measure: Cmin of buprenorphine and metabolites in plasma
timeFrame: 2 weeks post-randomization
measure: Cmin of buprenorphine and metabolites in plasma
timeFrame: 4 weeks post-randomization
measure: Fetal heart rate variability
timeFrame: Estimated gestational age (EGA) approximately 36 weeks
measure: Cmin of buprenorphine and metabolites in plasma
timeFrame: Estimated gestational age (EGA) approximately 36 weeks
measure: Cmax of buprenorphine and metabolites in plasma
timeFrame: Estimated gestational age (EGA) approximately 36 weeks
measure: Concentration of buprenorphine and metabolites in maternal plasma
timeFrame: Delivery
measure: Concentration of buprenorphine and metabolites in cord plasma
timeFrame: Delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital HOPE Clinic
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico Milagro Clinic
state: New Mexico
city: Cincinnati
country: United States
facility: University of Cincinnati Health Perinatal Addictions Program
state: Ohio
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
city: Pittsburgh
country: United States
facility: Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah SUPeRAD Clinic
state: Utah
city: Seattle
country: United States
facility: Addiction Recovery Services (ARS), Swedish Medical Center
state: Washington
city: Huntington
country: United States
facility: Marshall Health MARC Program
state: West Virginia
Study officials:
affiliation: University of Cincinnati
name: T. John Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References: