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Therapy and Peer Support for Opioid Use Disorder

N/A
Waitlist Available
Led By David S. Festinger, Ph.D.
Research Sponsored by Philadelphia College of Osteopathic Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (≥18 years)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating different types of psychosocial interventions to help people with opioid use disorder, with the goal of finding which interventions work best for different types of patients.

Who is the study for?
This trial is for adults over 18 with opioid use disorder who are eligible and agree to buprenorphine treatment. They must be stable enough not to need inpatient care, able to give informed consent, and provide contact information. People intoxicated, cognitively impaired or psychiatrically unstable at the start are excluded but can join later if conditions improve.
What is being tested?
The study tests different psychosocial treatments alongside medication-assisted treatment (MAT) for opioid addiction. It aims to find out which psychosocial approaches work best for various patients rather than using a standard method for all.
What are the potential side effects?
While specific side effects of the psychosocial interventions aren't detailed, typical reactions might include emotional discomfort or stress due to therapy discussions. Buprenorphine may cause drowsiness, dizziness, constipation, or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinalysis-confirmed opioid use
Secondary study objectives
ED utilization
Multidimensional problem severity
Opioid overdose rates
+4 more
Other study objectives
Provider outcome: Job satisfaction and stress

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Treatment as usualActive Control1 Intervention
Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.
Group II: Office based CBTActive Control1 Intervention
Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.
Group III: CRS/CPSActive Control1 Intervention
Those randomized to certified recovery specialist(CRS)/peer support specialist(CPS) will receive a CRS/CPS along with standard treatment from the FQHC.
Group IV: CBT+CRS/CPSActive Control1 Intervention
Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.

Find a Location

Who is running the clinical trial?

Philadelphia College of Osteopathic MedicineLead Sponsor
10 Previous Clinical Trials
977 Total Patients Enrolled
Boston UniversityOTHER
478 Previous Clinical Trials
9,994,470 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,919 Total Patients Enrolled
Public Health Management CorporationOTHER
17 Previous Clinical Trials
5,134 Total Patients Enrolled
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,708 Total Patients Enrolled
David S. Festinger, Ph.D.Principal InvestigatorPhiladelphia College of Osteopathic Medicine
Michelle R Lent, Ph.D.Principal InvestigatorPhiladelphia College of Osteopathic Medicine

Media Library

Psychosocial treatment Clinical Trial Eligibility Overview. Trial Name: NCT04257214 — N/A
Opioid Use Disorder Research Study Groups: Treatment as usual, Office based CBT, CRS/CPS, CBT+CRS/CPS
Opioid Use Disorder Clinical Trial 2023: Psychosocial treatment Highlights & Side Effects. Trial Name: NCT04257214 — N/A
Psychosocial treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04257214 — N/A
~86 spots leftby Jun 2026