What is the purpose of the study?

Medications like buprenorphine, methadone, and naltrexone are the gold standard for the treatment of opioid use disorder (OUD). Current clinical guidelines for the use of medications to treat opioid use disorder (MOUDs) recommend 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 treatment in this context overall and among different types of patients, as there is likely not a “one size fits all” best practice. This knowledge gap regarding how to best provide psychosocial services may limit the overall effectiveness of office-based opioid treatment with medications like buprenorphine.

This study seeks to address this knowledge gap by developing and conducting a randomized controlled trial (RCT) to examine the use of a tailored, adaptive approach to providing two widely used behavioral interventions, cognitive behavioral therapy and peer support, to patients who are initiating office-based buprenorphine treatment for OUD. In the study, we worked collaboratively with a multidisciplinary team to establish algorithms based on behavioral criteria to determine when each intervention should be implemented. The algorithm considers patient-level factors at treatment onset (i.e., life instability factors across several domains including being unstably housed or unemployed and substance use patterns that put one at risk for an overdose) and levels of treatment engagement and response. The research team is currently conducting a two group (adaptive approach vs. treatment as usual) RCT with 125 new buprenorphine patients from two federally qualified health centers in Philadelphia. Individuals complete a semi-structured interview assessment at baseline and quarterly thereafter for one year. We are examining several important outcomes including opioid use, treatment retention, and quality of life.

What have we found to date?
Although we have not yet completed final data collection and analysis, we have published several papers and presented findings at national conferences. Key findings to date highlight the need for additional psychosocial supports in this population. For example,

• Over half of participants currently use other substances in addition to opioids at study entry. Buprenorphine is designed to address opioid use and will have no impact on use of other drugs.
• Concurrent drug use is associated with early (within first three months) MOUD treatment dropout.
• Over one-third of participants report having significant thoughts of suicide over their lifetime, and over a quarter report suicidal attempts over their lifetime.

Student training program to increase diversity in research-related fields
As a step to address the underrepresentation of racial and ethnic minority professionals working in health services and research-related fields, the funds have allowed us to develop an addictions research training program in partnership with Lincoln University. The program provided didactic and experiential training in addictions and addictions research to four cohorts of psychology undergraduate students from Lincoln University.

Current publications from study
Dugosh, K. L., Lent, M. R., Burkley, S. B., Millard, C. M. K., McKay, J. R., & Kampman, K. M. (2023). Non-opioid substance use among patients who recently initiated office-based buprenorphine treatment. Journal of Addiction Medicine, 17(5), 612–614.
Lent, M. R., Dugosh, K. L., Hurstak, E., Callahan, H. R., & Mazur, K. (2023). Prevalence and predictors of suicidality among adults initiating office-based buprenorphine. Addiction Science & Clinical Practice, 18(1), 1-7. PMCID: PMC10233176
Lent, M.R., Gaither-Hardy, D., Favor, K.E., Harris, D., Cos, T. A., Millard, C., Kone, Z., Van Riper, A., & Dugosh, K. L. (2023). The development, implementation and early learnings of a training program to advance interest in behavioral research careers among undergraduate BIPOC students majoring in psychology. BMC Medical Education, 23:160.

Partners: Philadelphia College of Osteopathic Medicine, University of Pennsylvania, Lincoln University, Project Home, and PHMC Health Network

Funder: PA Department of Health through the non-formulary Commonwealth Universal Research Enhancement (CURE) program; SAP # 4100083338.