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Treating Opioid Patients' Pain and Sadness (TOPPS) for Opioid Use Disorder

Boston Medical Center, Boston, MA
Opioid Use DisorderTreating Opioid Patients' Pain and Sadness (TOPPS) - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is comparing the TOPPS intervention to a health education contact control condition to see if it is effective in decreasing the need to turn to substance misuse to avoid pain.

Eligible Conditions
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Month 12.

Baseline and Month 12
Change in Depression based on the PHQ-9
Mental Depression
Change in Pain Interference based on the BPI-I
Change in Pain Severity based on the VAS
Month 12.
Rates of buprenorphine treatment retention

Trial Safety

Phase-Based Safety

1 of 3

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1
Steps 2 Change (S2C)
2
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3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Health Education (HE)
1 of 2
Treating Opioid Patients' Pain and Sadness (TOPPS)
1 of 2

Active Control

Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Treating Opioid Patients' Pain and Sadness (TOPPS) · No Placebo Group · N/A

Treating Opioid Patients' Pain and Sadness (TOPPS)
Behavioral
Experimental Group · 1 Intervention: Treating Opioid Patients' Pain and Sadness (TOPPS) · Intervention Types: Behavioral
Health Education (HE)
Behavioral
ActiveComparator Group · 1 Intervention: Health Education (HE) · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treating Opioid Patients' Pain and Sadness (TOPPS)
2012
N/A
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 12.

Who is running the clinical trial?

Boston UniversityLead Sponsor
431 Previous Clinical Trials
9,876,147 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,300 Previous Clinical Trials
2,022,060 Total Patients Enrolled
Michael D Stein, MDPrincipal InvestigatorBoston University
4 Previous Clinical Trials
900 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently taking buprenorphine and do not plan to lower your dose over the next year.
You have been in pain for at least three months and the pain is affecting your daily life with a score of 4 or higher on a pain interference scale.
You have experienced severe pain in the last week that rates 4 or higher on a scale of 0-10.
You have been taking buprenorphine prescribed by your doctor for at least a month.
References

Frequently Asked Questions

Does this research involve participants above the age of forty?

"This trial is seeking individuals who have attained the age of consent and are yet to reach retirement." - Anonymous Online Contributor

Unverified Answer

Does my profile meet the criteria to join this research endeavor?

"In order to be considered part of this medical trial, applicants should have a history of opioid addiction and must range between the ages 18 to 65. Ultimately, 250 individuals will take part in the study." - Anonymous Online Contributor

Unverified Answer

Are there any current opportunities to enroll in this research trial?

"According to information housed on clinicaltrials.gov, this medical study is actively seeking participants since it was first posted August 21st 2019 and most recently updated August 31st 2022." - Anonymous Online Contributor

Unverified Answer

What is the patient sample size of this trial?

"Affirmative. As per the details available on clinicaltrials.gov, this medical trial commenced recruitment in August 2019 and has recently been updated. 250 volunteers need to be recruited at two different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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