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NCT03552120 · ClinicalTrials.gov registry record · NA
Serving Women Using Opioids During Pregnancy
A NA study, sponsored by University of Utah.
- Terminated
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03552120: Clinical Trial NA study, sponsored by University of Utah.
NCT03552120 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03552120, a NA study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid misuse and parenting behavior among pregnant women using opioids. Specific aims are: AIM 1: To evaluate the preliminary efficacy of MORE, relative to a supportive counseling control condition, on primary outcomes (opioid misuse) and secondary outcomes (opioid craving, psychological distress) among pregnant women using opioids. Hypothesis: Participants who participate in MORE will demonstrate significantly greater improvements than the supportive visit control group on: opioid misuse behaviors, opioid craving, and psychological distress. AIM 2: To test and quantify the degree to which the impact of MORE on opioid misuse is mediated by changes in cognitive, affective, and autonomic mechanisms relevant to this clinical population - including opioid attentional bias, negative emotion regulation, reward responsiveness, and physiological reactivity to infant cues. Hypothesis: The impact of MORE on craving and opioid misuse behaviors will be mediated by improvements in attentional bias toward opioid cues, negative emotion regulation and natural reward responsiveness on the emotion regulation task, and autonomic reactivity to infant cues. AIM 3: To evaluate the impact of MORE on mothers' perceptions of their ability to parent effectively and the quality of the mother-baby relationship. Hypothesis: Participants participating in MORE will report more positive beliefs about their ability to effectively parent. Participants who participated in MORE will interact more sensitively with their newborn. Exploratory AIM 1: To evaluate the efficacy of MORE, relative to a support group control condition, on co-regulation, as measured by an index of sympathetic nervous system functioning, among pregnant women using opioids. Hypothesis 1: Dyads in which the mother participated in MORE will demonstrate significantly greater dyadic synching of sympathetic activity as meas
Primary Outcome
The Current Opioid Misuse Measure misuse (COMM; α = .83) is a 17-item scale developed to help physicians identify patients misusing their prescribed opioids. Examples of items include: "In the past 30 days, how often have you needed to take pain medications belonging to someone else?" and, "In the past 30 days, how often have you used your pain medicine for symptoms other than for pain (e.g., to help your sleep, improve your mood, or relieve stress)?"
Interventions
- BEHAVIORAL Supportive Psychotherapy
- BEHAVIORAL MORE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2021-02-05 |
| Phase | NA |
Why NCT03552120 stopped before completion
NCT03552120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Supportive Psychotherapy is the first listed.
NCT03552120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03552120 about?
NCT03552120 is a clinical study titled "Serving Women Using Opioids During Pregnancy". The purpose of this study is to evaluate the effects of Mindfulness-Oriented Recovery Enhancement (MORE) on opioid misuse and parenting behavior among pregnant women using opioids. Specific aims are: AIM 1: To evaluate the preliminary efficacy of MORE, relative to a supportive counseling control c...
What is the current status of trial NCT03552120?
This trial is currently terminated. It is a NA study. The enrollment target is 60 participants. The study started on 2018-04-23. Estimated completion is 2021-02-05.
What interventions are being tested in trial NCT03552120?
The interventions under investigation include: Supportive Psychotherapy (BEHAVIORAL), MORE (BEHAVIORAL).
Who is sponsoring clinical trial NCT03552120?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03552120's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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