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

NCT04257214 | Active Not Recruiting DMC

• 1 other identifier: OBOT-2018C2-13158
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 5

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.

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)

• Urinalysis-confirmed opioid use

  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.

  Through 12 months post-study entry

Secondary Outcomes (7)

• Retention in Office-Based Buprenorphine Treatment

  Through 12 months post-study entry

• Quality of life assessment

  Through 12 months post-study entry

• Multidimensional problem severity

  Through 12 months post-study entry

• Urinalysis-confirmed use from other (non-opioid) drugs

  Through 12 months post-study entry

• ED utilization

  Through 12 months post-study entry

Other Outcomes (1)

• Provider outcome: Job satisfaction and stress

  Through study completion, an average of 1 year

Study Arms (4)

Treatment as usual

NO INTERVENTION

Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.

Office based CBT

ACTIVE COMPARATOR

Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.

Behavioral: Psychosocial treatment

CRS/CPS

ACTIVE COMPARATOR

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

CBT+CRS/CPS

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.

CBT+CRS/CPS; CRS/CPS; Office based CBT

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)
• 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

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

Study Sites (5)

AtlantiCare

Atlantic City, New Jersey, 08401, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Care Clinic

Philadelphia, Pennsylvania, 19123, United States

Location

Delaware Valley Community Health

Philadelphia, Pennsylvania, 19130, United States

Location

Berks Community Health Center

Philadelphia, Pennsylvania, 19601, United States

Location

Related Publications (22)

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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/

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  PMID: 25490943 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.

  PMID: 21403039 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.

  PMID: 23332439 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.

  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.

  PMID: 23260506 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.

  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.

  PMID: 22065255 BACKGROUND

• 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.

  PMID: 26882891 BACKGROUND

• 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.

  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

• Lent MR, Dugosh KL, Hurstak E, Callahan HR, Mazur K; Greater Philadelphia Opioid Use Disorder Research Group. Prevalence and predictors of suicidality among adults initiating office-based buprenorphine. Addict Sci Clin Pract. 2023 Jun 1;18(1):37. doi: 10.1186/s13722-023-00393-y.

  PMID: 37264472 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle R Lent, 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: January 29, 2020
• First Posted: February 5, 2020
• Study Start: July 15, 2020
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)