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New program eases pain and depression for patients on opioid addiction medication

NCT ID NCT03698669

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

163 people

The number who actually took part.

Started

Aug 2019

Finished

Dec 2024

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

Depression opiate dependence Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Stanley Street Treatment and Resources

    Fall River, Massachusetts, 02720, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.