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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Philadelphia College of Osteopathic Medicine
Philadelphia, Pennsylvania, United States
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.
Time frame: At baseline and 3,6,9, 12-month assessments
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At baseline and 3,6,9, 12-month assessments
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.