Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
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ClinicalTrials.gov Identifier: NCT04257214 |
Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : October 8, 2020
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Sponsor:
Philadelphia College of Osteopathic Medicine
Collaborators:
Boston University
Patient-Centered Outcomes Research Institute
Public Health Management Corporation
University of Pennsylvania
Information provided by (Responsible Party):
Philadelphia College of Osteopathic Medicine
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 29, 2020 | ||||||||
First Posted Date ICMJE | February 5, 2020 | ||||||||
Last Update Posted Date | October 8, 2020 | ||||||||
Actual Study Start Date ICMJE | July 15, 2020 | ||||||||
Estimated Primary Completion Date | April 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Urinalysis-confirmed opioid use [ Time Frame: Through 12 months post-study entry ] Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMA. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
Provider outcome: Job satisfaction and stress [ Time Frame: Through study completion, an average of 1 year ] We will hold focus groups with all key members of the clinical care team at each Federally Qualified Health Center (FQHC) site following completion of the trial to examine their perceptions about how the study interventions impacted their job-related stress and job satisfaction. The discussion will center on how the different interventions, separately or in combination, influenced the providers.
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder | ||||||||
Official Title ICMJE | Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine | ||||||||
Brief Summary | Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined. | ||||||||
Detailed Description | The study will evaluate the comparative effectiveness of two psychosocial approaches, Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists (CRS's)/ Certified Peer Specialists (CPS's) provided within the context of office-based buprenorphine treatment. Patients will be randomly assigned to receive either (1) standard Medication Management (MM) as typically provided at the site, (2) MM with office-based CBT, (3) MM with CRS/CPS, and (4) MM with both CBT and CRS/CPS. In MM, patients will be seen by providers at least weekly until stable, and stabilized patients will then be seen by the provider on a monthly basis. If a patient needs a higher level of care, they will be referred to appropriate specialty treatment to ensure their safety. In the CBT study arms, CBT will be provided through 12 individual manualized sessions scheduled to coincide with patients' MM appointments when possible. As outlined by the National Institute on Drug Abuse (NIDA), sessions will cover standard CBT topics and include exercises and homework. Meta-analyses and reviews have concluded that CBT is an effective treatment across a range of SUDs and has helped to enhance treatment retention, improve medication adherence, and address ancillary problems. In the CRS/CPS study arms, CRS's/CPS's will meet with clients following their first OBOT session to assist them in accessing community resources and overcoming treatment barriers, and provide ongoing patient navigation services to promote attendance at OBOT appointments. These appointments will occur either in-person or over the phone and all meetings will be tracked by the CRS/CPS. Studies indicate that peer-delivered services for individuals with mental health disorders are effective in engaging "difficult-to-reach" individuals and improving multidimensional outcomes. In the combined CBT/CRS study arm, clients will receive the individual CBT sessions and be assigned to a CRS/CPS. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Opioid Use Disorder | ||||||||
Intervention ICMJE | Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
440 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 30, 2023 | ||||||||
Estimated Primary Completion Date | April 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 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. DSM 5 criteria for OUD include:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT04257214 | ||||||||
Other Study ID Numbers ICMJE | OBOT-2018C2-13158 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Philadelphia College of Osteopathic Medicine | ||||||||
Study Sponsor ICMJE | Philadelphia College of Osteopathic Medicine | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Philadelphia College of Osteopathic Medicine | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |