Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

NCT03698669 | Completed Results DMC

• 2 other identifiers: H-380561R01DA045695
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid-Related Disorders

Keywords

Depression; Pain; Cognitive behavioral therapy (CBT); Buprenorphine; Behavioral health specialist (BHS); Primary care provider (PCP)

Outcome Measures

Primary Outcomes (3)

• Pain Interference Based on the Brief Pain Inventory

  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 completely."

  3 Months

• Pain Severity Based on the Brief Pain Inventory

  Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Participants will indicate "average" pain in the last week. Scores range between 0 and 10.

  3 Months

• Depression Based on the Patient Health Questionnaire-9

  The Patient Health Questionnaire (PHQ-9) will be used to measure depression severity and suicidality. It is the major depressive disorder module of the full PHQ. Scores range from 0-27, with scores less than or equal to 4 suggesting minimal depression, scores from 5 to 9 indicating mild depression, 10 to 14 indicating moderately depression, 15 to 19 reflecting moderately severe depression, and scores greater than 20 indicating severe depression.

  3 Months

Secondary Outcomes (1)

• Number of Participants Retained in Buprenorphine Treatment

  Month 12

Study Arms (2)

Treating Opioid Patients' Pain and Sadness (TOPPS)

EXPERIMENTAL

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.

Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)

Health Education (HE)

ACTIVE COMPARATOR

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.

Behavioral: Health Education (HE)

Interventions

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.

Health Education (HE)

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.

Treating Opioid Patients' Pain and Sadness (TOPPS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Stanley Street Treatment and Resources

Fall River, Massachusetts, 02720, United States

Location

Related Publications (2)

• Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Majeski A, Herman DS, Weisberg RB. Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study - A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine. Contemp Clin Trials. 2024 Aug;143:107608. doi: 10.1016/j.cct.2024.107608. Epub 2024 Jun 13.

  PMID: 38878997 BACKGROUND

• Haley DF, Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Herman DS, Anderson B, Weisberg RB. Associations of discomfort intolerance, discomfort avoidance, and cannabis and alcohol use among persons with chronic pain receiving prescription buprenorphine for opioid use disorder. Drug Alcohol Depend. 2024 Dec 1;265:112472. doi: 10.1016/j.drugalcdep.2024.112472. Epub 2024 Oct 24.

  PMID: 39488941 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Depression; Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Stein, MD
• Organization: Boston University

mdstein@bu.edu

617 358 1956

Study Officials

• Michael D Stein, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: August 21, 2019
• Primary Completion: June 28, 2024
• Study Completion: December 20, 2024
• Last Updated: January 8, 2026
• Results First Posted: June 26, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)