Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Key facts
- Who runs it
- Boston University
- Where
- Boston and Fall River, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 163 people enrolled
- Started
- 21 Aug 2019
- Ended
- 20 Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Treating Opioid Patients' Pain and Sadness (TOPPS)
- Health Education (HE)
- Record updated
- 8 January 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Expected surgery in the next 3 months
- Pain thought to be due to cancer, infection, or inflammatory arthritis
- Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI
- 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
- 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
Where in United States
- Boston Medical CenterBoston, United States
- Stanley Street Treatment and ResourcesFall River, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Treating Opioid Patients' Pain and Sadness (TOPPS)Treatment being tested
TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities.
- Health Education (HE)Existing treatment, for comparison
Participants randomized to the control HE condition are offered six telephone sessions led by the Behavioral Health Specialists. The first health session is around nutrition. At the remaining sessions, participants choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 January 2026