CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 163 enrolled
Drug / intervention
Treating Opioid Patients' Pain and Sadness (TOPPS) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03698669
NCT03698669N/ACompleted

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Boston University·interventional·Posted Oct 9, 2018·Updated Jan 8, 2026

In Brief

A clinical study evaluating Treating Opioid Patients' Pain and Sadness (TOPPS) and Health Education (HE) for Opioid-Related Disorders. Completed, enrolled 163 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartAug 21, 2019
Primary CompletionJun 28, 2024
Study CompletionDec 20, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.7 years ago

Interventions

Treating Opioid Patients' Pain and Sadness (TOPPS)behavioral

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)behavioral

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.