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Therapy and Peer Support for Opioid Use Disorder

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Urinalysis-confirmed opioid use

Secondary outcome measures

ED utilization

Multidimensional problem severity

Opioid overdose rates

+4 more

Other outcome measures

Provider outcome: Job satisfaction and stress

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Philadelphia College of Osteopathic MedicineLead Sponsor

9 Previous Clinical Trials

917 Total Patients Enrolled

Boston UniversityOTHER

454 Previous Clinical Trials

9,941,130 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,996,508 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the opportunity to join this research experiment still available?

"Affirmative, according to clinicaltrials.gov's records this research project is still enrolling participants. It was initially posted on July 15th 2020 and recently revised on October 6th of the same year. Presently, 440 subjects need to be recruited from 4 distinct medical facilities."

Answered by AI

How many participants are allocated to this clinical trial?

"Affirmative. Clinicaltrials.gov reveals the current recruitment status of this medical trial, which debuted on July 15th 2020 and was most recently revised on October 6th 2020. The team is looking for 440 patients to be recruited from 4 different clinical sites."

Answered by AI

Recent research and studies

Archives of Internal MedicineJournal

Collaborative Care of Opioid-addicted Patients in Primary Care Using Buprenorphine

Alford, Daniel P., Colleen T. LaBelle, Natalie Kretsch, Alexis Bergeron, Michael Winter, Michael Botticelli, and Jeffrey H. Samet. 2011. “Collaborative Care of Opioid-addicted Patients in Primary Care Using Buprenorphine”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinternmed.2010.541.

Drug and Alcohol DependenceJournal

Integrating Buprenorphine Maintenance Therapy into Federally Qualified Health Centers: Real-world Substance Abuse Treatment Outcomes

Haddad, Marwan S., Alexei Zelenev, and Frederick L. Altice. 2013. “Integrating Buprenorphine Maintenance Therapy into Federally Qualified Health Centers: Real-world Substance Abuse Treatment Outcomes”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2012.12.008.

AddictionJournal

Comparison of Behavioral Treatment Conditions in Buprenorphine Maintenance

Ling, Walter, Maureen Hillhouse, Alfonso Ang, Jessica Jenkins, and Jacqueline Fahey. 2013. “Comparison of Behavioral Treatment Conditions in Buprenorphine Maintenance”. Addiction. Wiley. doi:10.1111/add.12266.

AddictionJournal