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TapPro for Opioid Use Disorder (TapPro Trial)

N/A
Waitlist Available
Led By Hector R Perez, MD, MS
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TapPro Trial Summary

This trial is testing an intervention to help people taper off opioids in primary care. The intervention includes support for both patients and providers, and will be compared to usual care. The primary outcome is a decrease in opioid dose over six months, and the trial will also examine a clinically meaningful dose reduction as a secondary outcome.

Eligible Conditions
  • Opioid Use Disorder
  • Chronic Pain
  • Pain relief

TapPro Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in opioid dose over six months
Secondary outcome measures
Anxiety symptoms
Change in Quality of life score
Depressive symptoms
+8 more
Other outcome measures
Percent of patients attending clinic visits
Retention in care

TapPro Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TapProExperimental Treatment1 Intervention
Biweekly telephone and in-person visits with a clinician over three months. At each visit, a protocol adapted from the Prescription Opioid Taper Study will be provided to participants, who will learn about pain coping, distraction techniques, diaphragmatic breathing, sleep techniques, and progressive muscle relaxation techniques. All are specifically designed for patients with chronic pain on chronic opioid therapy. During visits, taper parameters will be discussed and the provider will work through a dose reduction schedule, if participants are in agreement. Additionally, urine drug screens will be obtained.
Group II: Usual CareActive Control1 Intervention
Participants randomized to the usual care arm will continue seeing their primary care providers as indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TapPro
2021
N/A
~10

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
286 Previous Clinical Trials
11,856,979 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,591 Total Patients Enrolled
Hector R Perez, MD, MSPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this research endeavor currently?

"The clinicaltrials.gov database records this medical trial as no longer seeking candidates, with its initial posting on May 4th 2021 and last edit occurring the following year. However, 614 other studies are actively recruiting patients at present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Developing and Pilot Testing an Opioid Tapering Protocol
Hector Perez 2021. "Developing and Pilot Testing an Opioid Tapering Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04257695.
~1 spots leftby Apr 2025
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