Developing and Pilot Testing an Opioid Tapering Protocol
CompletedNot applicableNCT04257695
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
- Conditions
- Interventions
- Behavioral: TapPro
- Sponsor
- Albert Einstein College of Medicine
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2021-05-04
- Primary completion
- 2023-08-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04257695