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Behavioral Intervention

Psychosocial support determined by adaptive treatment algorithm for Opioid Use Disorder

N/A

Waitlist Available

Led By Karen Dugosh, Ph.D.

Research Sponsored by Public Health Management Corporation

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 12 months post study entry

Awards & highlights

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.

Who is the study for?

This trial is for adults who have recently started buprenorphine treatment for opioid use disorder at a health center and can give informed consent. They must not need inpatient care, be intoxicated, cognitively impaired, or psychiatrically unstable at the start.Check my eligibility

What is being tested?

The study tests an adaptive psychosocial support method using recovery specialists and cognitive behavioral therapy tailored to each patient's needs during their outpatient buprenorphine treatment for opioid addiction.See study design

What are the potential side effects?

Since this trial focuses on psychosocial support rather than medication, side effects may include emotional discomfort or stress due to discussing personal issues during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post study entry 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 abstinence from opioids at 12 month follow up

Urinalysis-confirmed abstinence from opioids at 3 month follow up

Urinalysis-confirmed abstinence from opioids at 6 month follow up

+1 more

Secondary outcome measures

Abstinence from or reductions in use of other (non-opioid) psychoactive substances

Psychosocial functioning/Multidimensional problem severity

Quality of life assessment

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive InterventionExperimental Treatment1 Intervention

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Group II: Treatment As Usual (TAU)Active Control1 Intervention

Participants assigned to the TAU condition will be scheduled for buprenorphine medication management appointments and will receive OBOT at the FQHC and adjunctive psychosocial treatment as typically provided at the FQHC. The team will continue to meet with the patient during subsequent MAT visits on a decreasing frequency, with some slight site-specific variation. The schedule of MAT visits generally includes 3 clinic visits during the week of induction, 1-2 visits per week until the patient is stabilized, and monthly thereafter. Behavioral health clinicians provide support to the patient, discuss UDS results, assist with strategic problem-solving around recovery and adjustment to sobriety, and monitor the patient's engagement in MAT.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Public Health Management CorporationLead Sponsor

16 Previous Clinical Trials

5,209 Total Patients Enrolled

Philadelphia College of Osteopathic MedicineOTHER

9 Previous Clinical Trials

1,232 Total Patients Enrolled

Lincoln UniversityUNKNOWN

Frequently Asked Questions

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

Could you elucidate the fundamental aims of this trial?

"The main focus of the study is to measure opioid abstinence in participants at the 12-month follow up, examining this through urinalysis. Additionally, Quality of Life will be assessed with Short Form-36 (SF-36), while Psychosocial functioning and Multidimensional problem severity are tracked using Addiction Severity Index Lite (ASI-Lite). Finally, Retention in buprenorphine based Outpatient Opioid Treatment programmes' efficacy is monitored as a secondary outcome."

Answered by AI

What is the extent of recruitment for this research endeavor?

"Indeed, the information available on clinicaltrials.gov shows that recruitment for this medical trial is currently underway. The study was initially posted in September 2020 and revised lastly in November of the same year. 250 participants are being sought after to be evaluated across 2 sites."

Answered by AI

Are there any vacancies in the trial that would allow participants to join?

"As per clinicaltrials.gov, this research project is still actively recruiting patients for participation. It was first posted on September 21st of 2020 and has been updated most recently on November 24th of the same year."

Answered by AI

Recent research and studies

Drug and Alcohol DependenceJournal

Treatment Use, Perceived Need, and Barriers to Seeking Treatment for Substance Abuse and Mental Health Problems Among Older Adults Compared to Younger Adults

Choi, Namkee G., Diana M. DiNitto, and C. Nathan Marti. 2014. “Treatment Use, Perceived Need, and Barriers to Seeking Treatment for Substance Abuse and Mental Health Problems Among Older Adults Compared to Younger Adults”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2014.10.004.

Archives of Internal MedicineJournal

Initial and Maintenance Naltrexone Treatment for Alcohol Dependence Using Primary Care Vs Specialty Care

O'Malley, Stephanie S., Bruce J. Rounsaville, Conor Farren, Kee Namkoong, Ran Wu, Jane Robinson, and Patrick G. O'Connor. 2003. “Initial and Maintenance Naltrexone Treatment for Alcohol Dependence Using Primary Care Vs Specialty Care”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.163.14.1695.

Drug and Alcohol DependenceJournal

Developing Adaptive Treatment Strategies in Substance Abuse Research

Murphy, Susan A., Kevin G. Lynch, David Oslin, James R. McKay, and Tom TenHave. 2007. “Developing Adaptive Treatment Strategies in Substance Abuse Research”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2006.09.008.

American Journal on AddictionsJournal