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NCT03698669 · ClinicalTrials.gov registry record · NA
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 163
- Enrollment target
NCT03698669: Completed NA study, sponsored by Boston University.
NCT03698669 is a NA study that has completed, run by Boston University. The registered enrollment target is 163 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03698669, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 163 participants
- Enrollment target
Study 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.
Primary Outcome
The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents "does not interfere" and 10 indicates "interferes complete
Interventions
- BEHAVIORAL Health Education (HE)
- BEHAVIORAL Treating Opioid Patients' Pain and Sadness (TOPPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2024-12-20 |
| Phase | NA |
What the finished NCT03698669 record still lists
NCT03698669 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Health Education (HE) is the first listed.
NCT03698669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03698669 about?
NCT03698669 is a clinical study titled "Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings". 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 (...
What is the current status of trial NCT03698669?
This trial is currently completed. It is a NA study. The enrollment target is 163 participants. The study started on 2019-08-21. Estimated completion is 2024-12-20.
What interventions are being tested in trial NCT03698669?
The interventions under investigation include: Health Education (HE) (BEHAVIORAL), Treating Opioid Patients' Pain and Sadness (TOPPS) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03698669?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03698669's enrollment target sits among peer trials
163 627th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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