What side effects are associated with this type of intervention?

Behavioral treatments for Opioid Use Disorder, such as those involving behavioral activation and psychoeducation, generally have minimal physical side effects but may cause emotional discomfort as patients confront challenging issues. Pharmacologic treatments like buprenorphine and methadone are effective but come with side effects including constipation, nausea, vomiting, sedation, impaired psychomotor function, and urinary retention. These medications also carry risks of misuse and overdose, particularly when combined with other central nervous system depressants like benzodiazepines or alcohol.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including buprenorphine, methadone, and naltrexone. Buprenorphine, often combined with naloxone, is used in various formulations such as sublingual tablets and buccal films. Methadone is a long-acting opioid agonist used in maintenance therapy, while naltrexone is an opioid antagonist available in oral and extended-release injectable forms. These medications are frequently used in conjunction with behavioral therapies, such as cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET), to address the psychological aspects of addiction. The TOPPS trial specifically integrates behavioral activation and psychoeducation to manage pain and reduce opioid misuse, highlighting the importance of combining pharmacological and psychosocial interventions in OUD treatment.

What other types of research exist?

Promising novel alternatives to TOPPS for OUD patients include: 1) A community pharmacy intervention that integrates behavioral strategies to address opioid misuse, currently being tested in a pilot randomized clinical trial. 2) The Pain E-Consult Program (PEP), a multidisciplinary telementoring service based on the ECHO model, which has shown effectiveness in reducing opioid use in outpatient settings. 3) A shared decision-making tool designed to empower patients and maximize the use of non-opioid analgesics, which has been tested in a randomized controlled trial for postoperative pain management.

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TOPPS for Chronic Pain in Opioid Use Disorder (TOPPS Trial)

N/A

Waitlist Available

Led By Michael D Stein, MD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Score of at least 1 on PHQ-2 during prescreen or score of greater than or equal to 8 on PHQ-9 during in person screening

Pain severity of 4 or higher on a numerical rating scale (0-10) indicating 'worst pain in the last week'

Must not have

Not able to complete interviews in English

Expected surgery in the next 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a therapy called TOPPS for people with opioid use disorder who are being treated with buprenorphine. Buprenorphine is an effective treatment for opioid dependence that can be provided in a primary care setting. TOPPS helps patients understand and manage their pain and sadness through education, coaching, and goal-setting. The aim is to reduce their need to misuse opioids by improving their overall well-being.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder and chronic pain, who have been on buprenorphine treatment for at least a month. Participants should experience significant pain interference and may also have depression. They must not be planning major changes like moving or surgery within the next year, nor have certain psychiatric conditions or recent heavy drug use.

What is being tested?

The study compares TOPPS—a program addressing pain, depression, and substance misuse through education and behavioral activation—with standard health education in primary care settings. The goal is to reduce reliance on substances for managing pain over a period of 12 months.

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, side effects are minimal compared to drug trials. However, discussing painful topics might temporarily increase emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have shown signs of depression based on a screening test.

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My worst pain in the last week was 4 or more on a scale of 0 to 10.

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I will continue taking buprenorphine without reducing the dose for the next year.

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I am between 18 and 65 years old.

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I have been prescribed buprenorphine by my current doctor for at least a month.

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I have had chronic pain for at least three months with moderate to severe impact on my daily life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot complete interviews in English.

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I am scheduled for surgery within the next 3 months.

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My pain is caused by my cancer, an infection, or arthritis.

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I plan to move within a year and will need to change my Buprenorphine provider.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression based on the PHQ-9

Change in Pain Interference based on the BPI-I

Change in Pain Severity based on the VAS

Secondary study objectives

Rates of buprenorphine treatment retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treating Opioid Patients' Pain and Sadness (TOPPS)Experimental Treatment1 Intervention

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.

Group II: Health Education (HE)Active Control1 Intervention

After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treating Opioid Patients' Pain and Sadness (TOPPS)

2012

N/A

~30

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opioid Use Disorder (OUD) include medications like methadone, buprenorphine, and naltrexone, as well as psychosocial interventions such as behavioral activation and psychoeducation. Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as other opioids, reducing cravings and withdrawal symptoms without producing the same high. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the feeling of euphoria. Behavioral activation focuses on increasing engagement in meaningful activities to improve mood and reduce reliance on opioids, while psychoeducation provides patients with information about their condition and coping strategies. These treatments are crucial for OUD patients as they address both the physiological and psychological aspects of addiction, promoting long-term recovery and reducing the risk of relapse.

Outcomes of a Specialized Interdisciplinary Approach for Patients with Cancer with Aberrant Opioid-Related Behavior.Opioid use by patients in an orthopedics spine clinic.