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Patient Navigation for Pregnancy

N/A
Waitlist Available
Led By Gerald Cochran, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial aims to help pregnant women with opioid use disorder by providing targeted prevention activities and linking them to treatment in order to reduce harms to them and their offspring.

Eligible Conditions
  • Pregnancy
  • Opioid Use Disorder
  • Pregnancies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Medication-Assisted Treatment (MAT)
Linkage/Retention in Psychosocial Services
Opioid Abstinence
+1 more
Secondary outcome measures
Adequacy of Prenatal Care
Child and mother bond following delivery
Anxiety
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patient NavigationExperimental Treatment1 Intervention
The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
Group II: ControlActive Control1 Intervention
The standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,616 Total Patients Enrolled
University of PittsburghOTHER
1,720 Previous Clinical Trials
16,342,705 Total Patients Enrolled
Gerald Cochran, PhDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
350 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Contemporary Clinical TrialsJournal
A Pilot Multisite Study of Patient Navigation for Pregnant Women with Opioid Use Disorder
Cochran, Gerald, Marcela C. Smid, Elizabeth E. Krans, M. Aryana Bryan, Adam J. Gordon, Brad Lundahl, John Silipigni, Benjamin Haaland, and Ralph Tarter. 2019. “A Pilot Multisite Study of Patient Navigation for Pregnant Women with Opioid Use Disorder”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2019.105888.
Substance Use & MisuseJournal
Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment
Bryan, M. Aryana, Debesh Mallik, Gerald Cochran, and Brad Lundahl. 2022. “Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment”. Substance Use & Misuse. Informa UK Limited. doi:10.1080/10826084.2022.2046090.
clinicaltrials.govStudy
Optimizing Pregnancy and Treatment Interventions for Moms 2.0
Jerry Cochran 2019. "Optimizing Pregnancy and Treatment Interventions for Moms 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03833245.
~17 spots leftby Apr 2025
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