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Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Behavioral: Psychosocial treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
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.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.

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.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.

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.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257214


Contacts
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Contact: David S. Festinger, Ph.D. 215-871-6546 DavidFe@pcom.edu
Contact: Kaitlyn R. MacLennan, B.A. 215-985-2000 kmaclennan@phmc.org

Locations
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United States, New Jersey
AtlantiCare Not yet recruiting
Atlantic City, New Jersey, United States, 08401
Contact: Sandra Festa, M.S.W.         
United States, Pennsylvania
Care Clinic Recruiting
Philadelphia, Pennsylvania, United States, 19123
Contact: Olulafunmike Ojewoye, M.D.         
Delaware Valley Community Health Not yet recruiting
Philadelphia, Pennsylvania, United States, 19130
Contact: Julia DeJoseph, M.D.         
Berks Community Health Center Recruiting
Philadelphia, Pennsylvania, United States, 19601
Contact: Helen Wooten, LCSW         
Sponsors and Collaborators
Philadelphia College of Osteopathic Medicine
Boston University
Patient-Centered Outcomes Research Institute
Public Health Management Corporation
University of Pennsylvania
Investigators
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Principal Investigator: David S. Festinger, Ph.D. Philadelphia College of Osteopathic Medicine
Publications:
Substance Abuse and Mental Health Services Administration. Clinical guidelines for the use of buprenorphine in the treatment of opioid addiction. Treatment Improvement Protocol (TIP) Series, No. 40 (SMA 04-3939). Rockville, MD: U.S. Department of Health and Human Services; 2004.
Department of Health and Human Services. Medication assisted treatment for opioid use disorder (42 CFR Part 8, RIN 0930-AA22). Rockville, MD: Substance Abuse and Mental Health Services Administration.
Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database of Systematic Reviews; 2011. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21901695. Accessed September 6, 2018.

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Responsible Party: Philadelphia College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT04257214    
Other Study ID Numbers: OBOT-2018C2-13158
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philadelphia College of Osteopathic Medicine:
Opioid Use
Buprenorphine
Psychosocial Treatment
Medication Assisted Treatment
Cognitive Behavioral Therapy
Peer Support
Opioid Use Disorder
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders