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

NCT06359340 | Active Not Recruiting DMC

• 1 other identifier: OBOT-2018C2-13158
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Opioid-use Disorder

Keywords

Opioid Use; Buprenorphine; Psychosocial Treatment; Medication Assisted Treatment; Cognitive Behavioral Therapy; Peer Support; Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Days Retained in Office-Based Buprenorphine Treatment

  Through 12 months

• Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry

  At baseline and 3,6,9, 12-month assessments

• Changes in multidimensional problem severity from baseline through one year post-study entry

  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

  At baseline and 3,6,9, 12-month assessments

• Changes in ED utilization from baseline to one year post-study entry

  At baseline and 3,6,9, 12-month assessments

Other Outcomes (1)

• Job satisfaction and stress

  12 months following the end of recruitment

Study Arms (4)

MAT- OBOT

ACTIVE COMPARATOR

Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment.

Behavioral: Psychosocial treatment

MAT+ office-based CBT

ACTIVE COMPARATOR

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT.

Behavioral: Psychosocial treatment

MAT+ CRS/Peer Support Specialist

ACTIVE COMPARATOR

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS.

Behavioral: Psychosocial treatment

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.

Behavioral: Psychosocial treatment

Interventions

Psychosocial treatment BEHAVIORAL

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

MAT+ CRS/Peer Support Specialist; MAT+ both CBT and CRS/Peer Support Specialist; MAT+ office-based CBT; MAT- OBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years)
• Meet DSM 5 criteria for moderate to severe OUD;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Management Corporation: lead
• Boston University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Philadelphia College of Osteopathic Medicine: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Philadelphia College of Osteopathic Medicine

Philadelphia, Pennsylvania, 19131, United States

Location

Related Publications (21)

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  PMID: 26406300 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/

  PMID: 22514846 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/

  PMID: 23762965 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.

  PMID: 26808307 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.

  PMID: 27471920 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.

  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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• 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.

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  PMID: 18198270 BACKGROUND

• Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005031. doi: 10.1002/14651858.CD005031.pub4.

  PMID: 21901695 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.

  PMID: 20599130 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.

  PMID: 22614936 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.

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• 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.

  PMID: 23734858 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.

  PMID: 17372805 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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• 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.

  PMID: 29143483 BACKGROUND

• 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.

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  PMID: 24838535 BACKGROUND

• 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.

  PMID: 27776678 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• David S Festinger, Ph.D.

  Philadelphia College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: April 11, 2024
• Study Start: March 13, 2020
• Primary Completion: May 30, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)