CompletedNot Applicable

Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients

United States125 participantsStarted 2020-09-21

Plain-language summary

The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks; * Not require an inpatient level of care as determined by the healthcare provider; and * Be capable of providing valid contact information and informed consent. Exclusion Criteria: * Patient is under the age of 18; * Co-morbid psychiatric disorder indicating the need for more intensive residential treatment * Patient is unable to provide informed consent. Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested an adaptive approach to psychosocial support alongside buprenorphine — can you explain what 'adaptive' means here, and whether the type or intensity of counseling was adjusted based on how patients were responding to treatment?
2Since the trial is completed, have any results been published showing whether patients who received this adaptive psychosocial support were more likely to test negative for opioids at the 3, 6, 9, or 12 month checkpoints compared to those who received standard care?
3Buprenorphine is already an established medication for opioid use disorder — how does adding this kind of structured psychosocial support compare to what I'd receive through a standard buprenorphine program, and is there any reason to think one approach might suit my situation better?
4Given that this trial is now completed and no longer enrolling, are there similar studies still recruiting, or would you recommend a treatment plan based on what this research has found so far?
5How would the level of counseling involvement required in a trial like this fit with my day-to-day life, and is that something we should factor into deciding what kind of support structure makes sense for my recovery?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinalysis-confirmed abstinence from opioids at 3 month follow up

Timeframe: 3 months post study entry

Urinalysis-confirmed abstinence from opioids at 6 month follow up

Timeframe: 6 months post study entry

Urinalysis-confirmed abstinence from opioids at 9 month follow up

Timeframe: 9 months post study entry

Urinalysis-confirmed abstinence from opioids at 12 month follow up

Timeframe: 12 months post study entry

Trial details

NCT IDNCT04650386

SponsorPublic Health Management Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Opioid-use Disorder trials