Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy (NCT03831113) | Clinical Trial Compass
TerminatedPhase 2
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
Stopped: poor recruitment
United States13 participantsStarted 2019-04-13
Plain-language 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 and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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.