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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 : August 14, 2020
Sponsor:
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
First Submitted Date  ICMJE January 29, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date August 14, 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
 (submitted: February 4, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • Retention in Office-Based Buprenorphine Treatment [ Time Frame: Through 12 months post-study entry ]
    Information from the electronic health record (EHR) will be used to determine engagement in OBOT. We will obtain data from the EHR reflecting OBOT-related data including appointments attended, prescription refill information, and service dates. A patient will be identified as having dropped out of OBOT when 30 days without current buprenorphine prescription or 30 days without meeting with provider have passed.
  • Quality of life assessment [ Time Frame: Through 12 months post-study entry ]
    Quality of life will be measured using the Short Form-36 (SF-36). The SF-36 is a self-report inventory that assesses eight dimensions of physical and mental health-related quality of life. The SF-36 has been shown to have high reliability and validity. The SF-36 individual item scores are recoded to values from 0-100. Items in the same scale are then averaged together to create the 8 scale scores. The scales include physical functioning, role limitations die to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score indicates a more positive outcome in the scale.
  • Multidimensional problem severity [ Time Frame: Through 12 months post-study entry ]
    Multidimensional problem severity, a secondary outcome, will be measured using the Addiction Severity Index-Lite (ASI-Lite). The ASI-Lite is a reliable and valid multidimensional assessment that provides composite scores reflecting current problem severity in the medical, employment, alcohol, drug, legal, family/social, and psychiatric areas. The Addiction Severity Index-Lite yields problem severity scores for the following psychosocial dimensions: drug, alcohol, employment, medical, legal, psychiatric, and family/social. Within each dimension, scores can range from 0 to 1 with higher scores indicating higher problem severity.
  • Urinalysis-confirmed use from other (non-opioid) drugs [ Time Frame: Through 12 months post-study entry ]
    Results from the CLIAwaived® 14-panel test and fentanyl strip described above for the primary outcome will be used as an indicator of this outcome.
  • ED utilization [ Time Frame: Through 12 months post-study entry ]
    The Addiction Severity Index-Lite (ASI-Lite) yields problem severity scores for the following psychosocial dimensions: drug, alcohol, employment, medical, legal, psychiatric, and family/social. Within each dimension, scores can range from 0 to 1 with higher scores indicating higher problem severity. The ASI-Lite captures the number of ED visits that the patient experienced during the given timeframe (i.e., past 90 days).
  • Opioid overdose rates [ Time Frame: Through 12 months post-study entry ]
    The ASI-Lite (see above) captures the number of opioid overdoses that a patient experienced during the given timeframe (i.e., past 90 days). In addition, opioid overdoses will be extracted from the patient's clinical record.
  • Treatment satisfaction [ Time Frame: Through 12 months post-study entry ]
    Treatment satisfaction will be measured using a subscale from the Client Satisfaction Questionnaire-8. The CSQ-8 measures patient therapeutic engagement in and satisfaction with treatment. Individual scores from the 8 items are added and scores can range from 8-32 with a higher score indicating greater satisfaction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 4, 2020)
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.
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
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.
Study Arms  ICMJE
  • No Intervention: Treatment as usual
    Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.
  • Active Comparator: Office based CBT
    Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.
    Intervention: Behavioral: Psychosocial treatment
  • Active Comparator: CRS/CPS
    Those randomized to certified recovery specialist(CRS)/peer support specialist(CPS) will receive a CRS/CPS along with standard treatment from the FQHC.
    Intervention: Behavioral: Psychosocial treatment
  • Active Comparator: CBT+CRS/CPS
    Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.
    Intervention: Behavioral: Psychosocial treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2020)
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:

  • Adults (≥18 years)
  • Be deemed eligible for buprenorphine treatment for OUD by the FQHC treatment provider and agree to engage in this treatment;
  • Not require an inpatient level of care as determined by the healthcare provider;
  • Be capable of providing valid contact information and informed consent; and
  • Permit the research team to use and disclose their protected health information (PHI).

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:

  • Taking opioids in larger amounts or longer than intended;
  • Failed efforts to quit or cut back;
  • Spending a lot of time obtaining the opioid;
  • Craving or urges to use;
  • Repeated inability to carry out major work, school, or home obligations;
  • Continued use despite persistent or recurring interpersonal problems worsened by opioid use;
  • Stopping or reducing important social, recreational activities due to opioid use;
  • Recurrent use of opioids in physically hazardous situations;
  • Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance;
  • Tolerance; and
  • Withdrawal. Moderate OUD severity is denoted by the presence of 4 or 5 of these symptoms and severe OUD is denoted by 6 or more symptoms. Patients will be excluded from the study if their SUD is primarily for a different substance, or their co-morbid psychiatric needs indicate enhanced needs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David S. Festinger, Ph.D. 215-871-6546 DavidFe@pcom.edu
Contact: Kaitlyn R. MacLennan, B.A. 215-985-2000 kmaclennan@phmc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04257214
Other Study ID Numbers  ICMJE OBOT-2018C2-13158
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philadelphia College of Osteopathic Medicine
Study Sponsor  ICMJE Philadelphia College of Osteopathic Medicine
Collaborators  ICMJE
  • Boston University
  • Patient-Centered Outcomes Research Institute
  • Public Health Management Corporation
  • University of Pennsylvania
Investigators  ICMJE
Principal Investigator: David S. Festinger, Ph.D. Philadelphia College of Osteopathic Medicine
PRS Account Philadelphia College of Osteopathic Medicine
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP