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

• ClinicalTrials.gov Identifier: NCT04257214
• Recruitment Status: Recruiting
• First Posted: February 5, 2020
• Last Update Posted: July 16, 2020
• 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

• First Submitted Date: January 29, 2020
• First Posted Date: February 5, 2020
• Last Update Posted Date: July 16, 2020
• Actual Study Start Date: July 15, 2020
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Opioid Use Disorder

Intervention

Behavioral: Psychosocial treatment

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

Study Arms

• 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 *

• Kampman K, Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med. 2015 Sep-Oct;9(5):358-67. doi: 10.1097/ADM.0000000000000166.
• 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.
• Davoli M, Amato L, Clark N, Farrell M, Hickman M, Hill S, Magrini N, Poznyak V, Schünemann HJ. The role of Cochrane reviews in informing international guidelines: a case study of using the Grading of Recommendations, Assessment, Development and Evaluation system to develop World Health Organization guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. Addiction. 2015 Jun;110(6):891-8. doi: 10.1111/add.12788. Epub 2014 Dec 10.
• Dugosh K, Abraham A, Seymour B, McLoyd K, Chalk M, Festinger D. A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction. J Addict Med. 2016 Mar-Apr;10(2):93-103. doi: 10.1097/ADM.0000000000000193. Review.
• Schwartz RP. When Added to Opioid Agonist Treatment, Psychosocial Interventions do not Further Reduce the Use of Illicit Opioids: A Comment on Dugosh et al. J Addict Med. 2016 Jul-Aug;10(4):283-5. doi: 10.1097/ADM.0000000000000236.
• 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.
• Fiellin DA, Moore BA, Sullivan LE, Becker WC, Pantalon MV, Chawarski MC, Barry DT, O'Connor PG, Schottenfeld RS. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008 Mar-Apr;17(2):116-20. doi: 10.1080/10550490701860971.
• Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
• Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013 Jul 1;131(1-2):127-35. doi: 10.1016/j.drugalcdep.2012.12.008. Epub 2013 Jan 17.
• Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry. 2008 Feb;165(2):179-87. doi: 10.1176/appi.ajp.2007.06111851. Epub 2008 Jan 15.
• 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.
• McHugh RK, Hearon BA, Otto MW. Cognitive behavioral therapy for substance use disorders. Psychiatr Clin North Am. 2010 Sep;33(3):511-25. doi: 10.1016/j.psc.2010.04.012. Review.
• Moore BA, Barry DT, Sullivan LE, Oʼconnor PG, Cutter CJ, Schottenfeld RS, Fiellin DA. Counseling and directly observed medication for primary care buprenorphine maintenance: a pilot study. J Addict Med. 2012 Sep;6(3):205-11. doi: 10.1097/ADM.0b013e3182596492.
• Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.
• Ling W, Hillhouse M, Ang A, Jenkins J, Fahey J. Comparison of behavioral treatment conditions in buprenorphine maintenance. Addiction. 2013 Oct;108(10):1788-98. doi: 10.1111/add.12266. Epub 2013 Jul 12.
• Moore BA, Fiellin DA, Barry DT, Sullivan LE, Chawarski MC, O'Connor PG, Schottenfeld RS. Primary care office-based buprenorphine treatment: comparison of heroin and prescription opioid dependent patients. J Gen Intern Med. 2007 Apr;22(4):527-30.
• Weiss RD, Potter JS, Fiellin DA, Byrne M, Connery HS, Dickinson W, Gardin J, Griffin ML, Gourevitch MN, Haller DL, Hasson AL, Huang Z, Jacobs P, Kosinski AS, Lindblad R, McCance-Katz EF, Provost SE, Selzer J, Somoza EC, Sonne SC, Ling W. Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. Arch Gen Psychiatry. 2011 Dec;68(12):1238-46. doi: 10.1001/archgenpsychiatry.2011.121. Epub 2011 Nov 7.
• Litz M, Leslie D. The impact of mental health comorbidities on adherence to buprenorphine: A claims based analysis. Am J Addict. 2017 Dec;26(8):859-863. doi: 10.1111/ajad.12644. Epub 2017 Nov 16.
• Bassuk EL, Hanson J, Greene RN, Richard M, Laudet A. Peer-Delivered Recovery Support Services for Addictions in the United States: A Systematic Review. J Subst Abuse Treat. 2016 Apr;63:1-9. doi: 10.1016/j.jsat.2016.01.003. Epub 2016 Jan 13. Review.
• Reif S, Braude L, Lyman DR, Dougherty RH, Daniels AS, Ghose SS, Salim O, Delphin-Rittmon ME. Peer recovery support for individuals with substance use disorders: assessing the evidence. Psychiatr Serv. 2014 Jul;65(7):853-61. doi: 10.1176/appi.ps.201400047. Review.
• Moore BA, Fiellin DA, Cutter CJ, Buono FD, Barry DT, Fiellin LE, O'Connor PG, Schottenfeld RS. Cognitive Behavioral Therapy Improves Treatment Outcomes for Prescription Opioid Users in Primary Care Buprenorphine Treatment. J Subst Abuse Treat. 2016 Dec;71:54-57. doi: 10.1016/j.jsat.2016.08.016. Epub 2016 Sep 2.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 4, 2020): 440
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2023
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: United States

Administrative Information

• NCT Number: NCT04257214
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Philadelphia College of Osteopathic Medicine
• Study Sponsor: Philadelphia College of Osteopathic Medicine

Collaborators

• Boston University
• Patient-Centered Outcomes Research Institute
• Public Health Management Corporation
• University of Pennsylvania

Investigators

• Principal Investigator: David S. Festinger, Ph.D.; Philadelphia College of Osteopathic Medicine

• PRS Account: Philadelphia College of Osteopathic Medicine
• Verification Date: July 2020