N/A
N=163
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03698669 ↗Enrolled (actual)
163
Serious AEs
14.1%
Results posted
Jun 2025
Primary outcome: Primary: Pain Interference Based on the Brief Pain Inventory — 5.01; 4.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treating Opioid Patients' Pain and Sadness (TOPPS) (Behavioral); Health Education (HE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Interference Based on the Brief Pain Inventory |
5.01; 4.67 | — |
| PRIMARY Pain Severity Based on the Brief Pain Inventory |
5.17; 5.02 | — |
| PRIMARY Depression Based on the Patient Health Questionnaire-9 |
10.91; 9.21 | — |
| SECONDARY Number of Participants Retained in Buprenorphine Treatment |
63; 61 | — |
Summary
Treating Opioid Patients' Pain and Sadness (TOPPS) focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a behavioral health specialist (BHS) trained extensively in the nature of pain and opioid misuse, including how to assess for red flags of opioid relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (PCP, BHS, and patient) and focuses on pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, and to foster patient's abilities to achieve their long-term life goals. In this study, TOPPS is compared to a health education contact-control condition among 250 persons with opioid use disorder recruited from two primary care based buprenorphine programs. The investigators will provide both interventions over 3 months, and follow the patients for a total of 12 months in order to observe both short-term and longer-term effects of TOPPS.
Eligibility Criteria
Inclusion Criteria
- Between 18 and 65 years of age
- Have chronic pain, defined as pain duration for at least three months with a mean score of 4 or higher on the Brief Pain Inventory (BPI) Pain Interference Scale
- Pain severity of 4 or higher on a numerical rating scale (0-10) indicating "worst pain in the last week"
- If using an antidepressant, the dose must be stable for the previous 2 months
- Has received buprenorphine from the current primary care provider for at least the last month
- Continuing buprenorphine with no plan to taper dose for the next 12 months
- Score of ≥4 on Personal Health Questionnaire-9 instrument (at least "mild" depression severity)
- Gives informed consent to participate in the study.
Exclusion Criteria
- Expected surgery in the next 3 months
- Pain thought to be due to cancer, infection, or inflammatory arthritis
- Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month
- Current (past month) mania or past year psychosis as determined via Structured Clinical Interview for DSM-5 (SCID) Module's A and B/C
- Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI
- Planning to stop using buprenorphine in the next 6 months
- Pregnancy or planned pregnancy in the next 6 months.
- Greater than 8 homeless nights in the past month
- Suicide ideation or behavior requiring immediate attention
- Not able to provide informed consent
- Not able to complete interviews in English
- Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
- Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone
- Headache/migraine as the only site of pain
Data sourced from ClinicalTrials.gov (NCT03698669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.