Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

Phase 2

Terminated

• Conditions: Opiate Addiction; Pregnancy

• Registration Number: NCT03831113
• Lead Sponsor: Steve N. Caritis, MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-1-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

Inclusion Criteria:<br><br> 1. On a stable dosing regimen of BUP for at least 2 weeks as part of an established<br> medication- assisted treatment (MAT) program.<br><br> 2. Willingness to undergo supervised dose reduction<br><br> 3. Subject willingness to be assigned to either the Magnitude, or Frequency group.<br><br> 4. Single gestation between 14-30 weeks at the initiation of the dose reduction<br><br> 5. On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data<br> points)<br><br> 6. Willingness to have urine samples tested for drugs of abuse and blood samples tested<br> for BUP+M concentrations during the Medical Supervised Withdrawal (MSW) clinic<br> appointments<br><br> 7. Willingness to attend weekly or biweekly MSW clinic appointments and to have daily<br> contact via text messaging and to complete daily logs of sleep quality, withdrawal<br> symptoms and symptoms of craving.<br><br> 8. Willingness to attend psychosocial support meetings as needed.<br><br>Exclusion Criteria:<br><br> 1. Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP),<br> or opioids other than BUP.<br><br> 2. Currently taking more than two mental health medications<br><br> 3. Active moderately severe depression (PHQ-9 score =15 or suicidal ideation)<br><br> 4. Current incarceration<br><br> 5. Lack of a phone or transportation to and from clinic<br><br> 6. Major fetal malformation<br><br> 7. Mother with significant vaginal bleeding or serious medical or obstetrical<br> complication that could adversely affect the study<br><br> 8. Planned delivery at another institution<br><br> 9. HIV or AIDS<br><br> 10. Diagnosis of schizoaffective disorder or psychosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Scores