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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA057443 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
| Weill Medical College of Cornell University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.
There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach.
Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers.
This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=160) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-Delivered Behavioral Activation ("Peer Activate") | Experimental | Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use. |
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| Treatment As Usual | No Intervention | Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-Delivered Behavioral Activation ("Peer Activate") | Behavioral | The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Month Polysubstance Use Urinalysis | Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. | Measured from baseline to 6-month follow-up |
| Six-Month Polysubstance Use Self Report | The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency. | Assessed between the baseline assessment 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Six-month OUD Treatment Retention | Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation. | Measured from intake through 6-month follow up |
| Six-month Buprenorphine Adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Three-month OUD Treatment Retention | Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at three months post MOUD initiation. | Measured from intake through 3-month follow up |
| Three-Month Polysubstance Use Urinalysis |
Inclusion Criteria:
Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morgan S Anvari, BA | Contact | 3014055095 | manvari@umd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jessica F Magidson, PhD | University of Maryland, College Park | Principal Investigator |
| Sarah M Kattakuzhy, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIPS Clinic | Not yet recruiting | Washington D.C. | District of Columbia | 20002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31525570 | Background | Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30. | |
| 21310539 | Background | Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21. |
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After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.
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Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
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At 3-month, 6-month and 12-months following the baseline assessment, a trained and randomization-blinded member of the research team will complete assessments with the participant.
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Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months. |
| Measured from intake to six-month follow-up |
| Six-month Self-Report Buprenorphine Adherence | The IRA Wilson will be utilized to assess self-report buprenorphine adherence | Assessed between the baseline assessment and 6-month follow-up |
| Six-Month Problems Associated with Substance Use | Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use. | Assessed between the baseline assessment and 6-month follow-up |
| Intervention Uptake | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. | Assessed between the baseline assessment and 6-month follow-up |
| Intervention Session Attendance | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured. | Assessed between the baseline assessment 6-month follow-up |
| Intervention Fidelity | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured. | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) |
Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. |
| Measured from baseline to 3-month follow-up. |
| Three-Month Polysubstance Use Self Report | The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency. | Measured from baseline to 3-month follow-up. |
| Three-Month Problems Associated with Substance Use | Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use. | Assessed between baseline assessment and 3-month follow-up. |
| Three-month Buprenorphine Adherence | Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 3 months will be assessed and calculated via the percent retained on MT for at least 3 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 3 months. | Measured over 3 months |
| Three-month Self-Report Buprenorphine Adherence | The IRA Wilson will be utilized to assess self-report buprenorphine adherence | Assessed between the baseline assessment and 3-month follow-up |
| Twelve-month OUD Treatment Retention | Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at twelve months post MOUD initiation. | Measured from intake through 12-month follow up |
| Twelve-Month Polysubstance Use Urinalysis | Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. | Measured from baseline to 12-month follow-up. |
| Twelve-Month Polysubstance Use Self Report | The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency. | Measured from baseline to 12-month follow-up. |
| Twelve-Month Problems Associated with Substance Use | Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use. | Assessed between the baseline and 12-month follow-up. |
| Twelve-month Buprenorphine Adherence | Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 12 months will be assessed and calculated via the percent retained on MT for at least 12 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 12 months. | Measured over 12 months |
| Twelve-month Self-Report Buprenorphine Adherence | The IRA Wilson will be utilized to assess self-report buprenorphine adherence | Assessed between the baseline assessment and 12-month follow-up |
| Six-month Treatment Cost | The resources required to implement and sustain the interventions (Peer Activate-MTU, and ETAU) will be identified via micro-costing techniques, using a tailored version of the Drug Abuse Treatment Cost Analysis Program (DATCAP) instrument, a standardized, customizable tool designed to capture intervention resources in multiple settings for the purpose of estimating costs. | Measured from baseline to 6-month follow-up |
| Six-month Healthcare Resource Utilization | Healthcare Resource Utilization by participants will be self-reported using time-anchoring methodology via the Non-study Medical and Other Services (NMOS) form, and will include non-study MOUD care, inpatient, outpatient, and emergency department services; SUD treatment medications; residential and outpatient SUD treatment days; hospital SUD detoxification days; and mental health treatment. | Measured from baseline to 6-month follow-up |
| Six-month Health-related Quality of Life | Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) instrument. | Measured from baseline to 6-month follow-up |
| Six-month Non-Medical and Other Resource Utilization | Use of non-medical and other resources from the societal perspective (e.g., school/workplace productivity, travel time to care, caregiver burden, etc.) will also be self-reported using the NMOS. | Measured from baseline to 6-month follow-up |
| Six-month Criminal and Legal Activities | Criminal and legal activities will be measured using the time-anchoring methodology via the Criminal-Legal Activities Form (CLAF). | Measured from baseline to 6-month follow-up |
| Overdose risk | Overdose risk will be assessed as a binary outcome (including both fatal and non-fatal overdoses). | Measured from baseline to 6-month follow-up |
| University of Maryland Baltimore (UMD Drug Treatment Center) | Not yet recruiting | Baltimore | Maryland | 21223 | United States |
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| University of Maryland, College Park | Not yet recruiting | College Park | Maryland | 20742 | United States |
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| Caroline County Behavioral Health | Recruiting | Denton | Maryland | 21629 | United States |
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| 23030605 | Background | Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3. |
| 30887824 | Background | Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19. |
| 28963853 | Background | Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19. |
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| 31082664 | Background | Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10. |
| 21709737 | Background | Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003. |
| 28799413 | Background | Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11. |
| 25204847 | Background | Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9. |
| 27478619 | Background | Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22. |
| 27461440 | Background | Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23. |
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| 32599495 | Background | Langabeer JR, Stotts AL, Cortez A, Tortolero G, Champagne-Langabeer T. Geographic proximity to buprenorphine treatment providers in the U.S. Drug Alcohol Depend. 2020 Aug 1;213:108131. doi: 10.1016/j.drugalcdep.2020.108131. Epub 2020 Jun 24. |
| 35932644 | Background | Magidson JF, Kleinman MB, Bradley V, Anvari MS, Abidogun TM, Belcher AM, Greenblatt AD, Dean D, Hines A, Seitz-Brown CJ, Wagner M, Bennett M, Felton JW. Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Int J Drug Policy. 2022 Oct;108:103813. doi: 10.1016/j.drugpo.2022.103813. Epub 2022 Aug 3. |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D000079524 | Narcotic-Related Disorders |
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