Developing and Pilot Testing an Opioid Tapering Protocol (TapPro)

Albert Einstein College of Medicine

Status: Completed

Conditions: Chronic Pain; Opioid Use; Analgesia

Treatments: Behavioral: TapPro

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04257695

K23DA044327 (U.S. NIH Grant/Contract)

2019-10910

Details and patient eligibility

About

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.

Full description

In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

TapPro

Experimental group

Description:

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.

Treatment:

Behavioral: TapPro

Usual Care

No Intervention group

Description:

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