Clinical trial NCT04257695: Developing and Pilot Testing an Opioid Tapering Protocol
Official title: Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use
Analgesia
Keywords: opioid
tapering
chronic pain
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in opioid dose over six months
timeFrame: Up to six months
Secondary outcomes:
measure: Opioid dose reduction
timeFrame: Up to six months
measure: Patient reported pain score
timeFrame: Up to six months
measure: Pain interference
timeFrame: Up to six months
measure: Pain related self-efficacy
timeFrame: Up to six months
measure: Change in Quality of life score
timeFrame: Up to six months
measure: Depressive symptoms
timeFrame: Up to six months
measure: Anxiety symptoms
timeFrame: Up to six months
measure: Pain catastrophizing
timeFrame: Up to six months
measure: Sleep quality
timeFrame: Up to six months
measure: Opioid Misuse
timeFrame: Up to six months
measure: Opioid Knowledge
timeFrame: Up to six months
Other outcomes:
measure: Retention in care
timeFrame: 12 months
measure: Percent of patients attending clinic visits
timeFrame: 6 months
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Hector R Perez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: