New program eases pain and depression for patients on opioid addiction medication
NCT ID NCT03698669
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a program called TOPPS for people taking buprenorphine for opioid addiction who also have chronic pain. The program uses counseling and education to help patients manage pain and avoid turning to substance misuse. 163 adults from primary care clinics took part, and researchers measured changes in pain, depression, and treatment retention over 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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163 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Between 18 and 65 years of age 2. 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 3. Pain severity of 4 or higher on a numerical rating scale (0-10) indicating "worst pain in the last week" 4. If using an antidepressant, the dose must be stable for the previous 2 months 5. Has received buprenorphine from the current primary care provider for at least the last month 6. Continuing buprenorphine with no plan to taper dose for the next 12 months 7. Score of ≥4 on Personal Health Questionnaire-9 instrument (at least "mild" depression severity) 8. Gives informed consent to participate in the study. Exclusion Criteria: 1. Expected surgery in the next 3 months 2. Pain thought to be due to cancer, infection, or inflammatory arthritis 3. Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month 4. Current (past month) mania or past year psychosis as determined via Structured Clinical Interview for DSM-5 (SCID) Module's A and B/C 5. Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI 6. Planning to stop using buprenorphine in the next 6 months 7. Pregnancy or planned pregnancy in the next 6 months. 8. Greater than 8 homeless nights in the past month 9. Suicide ideation or behavior requiring immediate attention 10. Not able to provide informed consent 11. Not able to complete interviews in English 12. Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future. 13. Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone 14. Headache/migraine as the only site of pain
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720, United States
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Other studies related to the condition(s) this trial covers.
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