Developing and Pilot Testing an Opioid Tapering Protocol

NCT04257695 | Completed

• 2 other identifiers: 2019-10910K23DA044327
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.

Conditions

Chronic Pain; Opioid Use; Analgesia

Keywords

opioid; tapering; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in opioid dose over six months

  Repeated measure analysis of opioid dosage over six months

  Up to six months

Secondary Outcomes (11)

• Opioid dose reduction

  Up to six months

• Patient reported pain score

  Up to six months

• Pain interference

  Up to six months

• Pain related self-efficacy

  Up to six months

• Change in Quality of life score

  Up to six months

Other Outcomes (2)

• Retention in care

  12 months

• Percent of patients attending clinic visits

  6 months

Study Arms (2)

TapPro

EXPERIMENTAL

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.

Behavioral: TapPro

Usual Care

NO INTERVENTION

Participants randomized to the usual care arm will continue seeing their primary care providers as indicated.

Interventions

TapPro BEHAVIORAL

Manualized intervention administered by a clinician to facilitate opioid tapering during clinical visits.

TapPro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18
• chronic prescription opioid use (\>3 monthly prescriptions from the clinic within prior 6 months)
• morphine milligram equivalents (MME) ≥50
• poorly controlled pain (PEG pain score ≥ 5/10)
• providers considering opioid taper but no reductions in opioid dose over the past 6 months.

You may not qualify if:

• Active cancer or other serious progressive illness, by medical review and by self-report
• Moderate or severe opioid use disorder, as per DSM-V
• Inability to give informed consent
• Active suicidal ideation.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Hector R Perez, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: May 4, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)