Status:
TERMINATED
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
Lead Sponsor:
Steve N. Caritis, MD
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Opiate Addiction
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental ...
Detailed Description
Opioid use has reached a staggering level and the associated deaths, neonatal consequences and economic impact are devastating. Buprenorphine and methadone are the two most commonly used medications f...
Eligibility Criteria
Inclusion
- On a stable dosing regimen of BUP for at least 2 weeks as part of an established medication- assisted treatment (MAT) program.
- Willingness to undergo supervised dose reduction
- Subject willingness to be assigned to either the Magnitude, or Frequency group.
- Single gestation between 14-30 weeks at the initiation of the dose reduction
- On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data points)
- Willingness to have urine samples tested for drugs of abuse and blood samples tested for BUP+M concentrations during the Medical Supervised Withdrawal (MSW) clinic appointments
- Willingness to attend weekly or biweekly MSW clinic appointments and to have daily contact via text messaging and to complete daily logs of sleep quality, withdrawal symptoms and symptoms of craving.
- Willingness to attend psychosocial support meetings as needed.
Exclusion
- Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids other than BUP.
- Currently taking more than two mental health medications
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Current incarceration
- Lack of a phone or transportation to and from clinic
- Major fetal malformation
- Mother with significant vaginal bleeding or serious medical or obstetrical complication that could adversely affect the study
- Planned delivery at another institution
- HIV or AIDS
- Diagnosis of schizoaffective disorder or psychosis
Key Trial Info
Start Date :
April 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03831113
Start Date
April 13 2019
End Date
December 22 2022
Last Update
August 29 2024
Active Locations (2)
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1
Univerity of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
High Risk Obstetrical Consultants
Knoxville, Tennessee, United States, 39720