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| Name | Class |
|---|---|
| Boston University | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| Philadelphia College of Osteopathic Medicine | OTHER |
| University of Pennsylvania |
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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, the 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.
The study will evaluate the comparative effectiveness of two psychosocial approaches, Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists 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, and (4) MM with both CBT and CRS. 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 study arms, CRS'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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAT- OBOT | Active Comparator | Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment. |
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| MAT+ office-based CBT | Active Comparator | Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT. |
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| MAT+ CRS/Peer Support Specialist | Active Comparator | Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS. |
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| MAT+ both CBT and CRS/Peer Support Specialist | Active Comparator | Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial treatment | Behavioral | Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry | Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. Investigators 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution. | At baseline and 3,6,9, 12-month assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Days Retained in Office-Based Buprenorphine Treatment | Information from the electronic health record (EHR) will be used to determine the number of days of engagement in OBOT. Investigators 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Job satisfaction and stress | Investigators 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. |
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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| Name | Affiliation | Role |
|---|---|---|
| David S Festinger, Ph.D. | Philadelphia College of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia College of Osteopathic Medicine | Philadelphia | Pennsylvania | 19131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26406300 | Background | 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. | |
| 22514846 | Background | Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Report No.: (SMA) 04-3939. Available from http://www.ncbi.nlm.nih.gov/books/NBK64245/ |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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| Through 12 months |
| Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year 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. For each subscale, scores may range from 0 to 100 with higher scores reflecting greater quality of life. | At baseline and 3,6,9, 12-month assessments |
| Changes in multidimensional problem severity from baseline through one year 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. Scores may range from 0 to 1 with higher scores indicating greater problem severity. | At baseline and 3,6,9, 12-month assessments |
| Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year 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. A binary variable reflecting other drug use versus no other drug use will be generated for this outcome. | At baseline and 3,6,9, 12-month assessments |
| Changes in ED utilization from baseline to one year post-study entry | The ASI-Lite (see above) captures the number of ED visits that the patient experienced during the given timeframe (i.e., past 90 days). | At baseline and 3,6,9, 12-month assessments |
| Changes in opioid overdose rates | 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. | At baseline and 3,6,9, 12-month assessments |
| Changes in treatment satisfaction from baseline to one year post-study entry | Treatment satisfaction will be measured using a subscale from the Client Satisfaction Questionnaire-8 (19). The CSQ-8 measures patient therapeutic engagement in and satisfaction with treatment. Scores may range from 8 to 32 with higher scores indicating greater treatment satisfaction. | At baseline and 3,6,9, 12-month assessments |
| 12 months following the end of recruitment |
| 23762965 | Background | Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK143185/ |
| 26808307 | Background | 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. |
| 27471920 | Background | 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. |
| Background | 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. |
| 18393054 | Background | 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. |
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| 23332439 | Background | 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. |
| 18198270 | Background | 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. |
| Background | 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. |
| 20599130 | Background | 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. |
| 22614936 | Background | Moore BA, Barry DT, Sullivan LE, O'connor 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. |
| 23260506 | Background | 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. |
| 23734858 | Background | 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. |
| 17372805 | Background | 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. doi: 10.1007/s11606-007-0129-0. |
| 22065255 | Background | 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. |
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| Background | Cutter CJ, Moore BA, Barry D, Fiellin LE, Schottenfeld RS, Fiellin D, O'Connor P. Cognitive behavioral therapy improves treatment outcome for prescription opioid users in primary care based buprenorphine/naloxone treatment. Drug Alcohol Depen. 2015;146:e255. |