Psychosocial support determined by adaptive treatment algorithm for Drug Abuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Drug Abuse+2 More
Psychosocial support determined by adaptive treatment algorithm - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare an adaptive treatment approach for patients with buprenorphine for opioid use disorder to usual care delivered in federally qualified health centers in Philadelphia.

Eligible Conditions
  • Drug Abuse
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Drug Abuse

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 12 months post study entry

Month 12
Urinalysis-confirmed abstinence from opioids at 12 month follow up
Month 3
Urinalysis-confirmed abstinence from opioids at 3 month follow up
Month 6
Urinalysis-confirmed abstinence from opioids at 6 month follow up
Month 9
Urinalysis-confirmed abstinence from opioids at 9 month follow up
Month 12
Abstinence from or reductions in use of other (non-opioid) psychoactive substances
Psychosocial functioning/Multidimensional problem severity
Quality of life assessment
Retention in buprenorphine-based OBOT
Treatment satisfaction

Trial Safety

Safety Progress

1 of 3

Other trials for Drug Abuse

Trial Design

2 Treatment Groups

Treatment As Usual (TAU)
1 of 2
Adaptive Intervention
1 of 2
Active Control
Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Psychosocial support determined by adaptive treatment algorithm · No Placebo Group · N/A

Adaptive Intervention
Behavioral
Experimental Group · 1 Intervention: Psychosocial support determined by adaptive treatment algorithm · Intervention Types: Behavioral
Treatment As Usual (TAU)NoIntervention Group · 1 Intervention: Treatment As Usual (TAU) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post study entry

Who is running the clinical trial?

Public Health Management CorporationLead Sponsor
13 Previous Clinical Trials
5,395 Total Patients Enrolled
Philadelphia College of Osteopathic MedicineOTHER
5 Previous Clinical Trials
701 Total Patients Enrolled
University of PennsylvaniaOTHER
1,816 Previous Clinical Trials
41,114,843 Total Patients Enrolled
Lincoln UniversityUNKNOWN
Karen Dugosh, Ph.D.Principal InvestigatorPHMC
1 Previous Clinical Trials
228 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
We have started providing office-based buprenorphine treatment for opioid use disorder at our federally qualified health center within the last month.
Do not need to stay in a hospital to receive care.
You must be able to provide valid contact information and informed consent in order to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References