Primary Care Intervention to Reduce Prescription Opioid Overdoses

Summary

The high rate of adverse events, including overdose, resulting from opioid pain medication use threatens the quality and safety of pain care in the Veterans Health Administration (VHA) and elsewhere and is a critical public health problem in the United States. Pain is a highly common condition among VHA patients, and opioid therapy constitutes a primary mode of pain treatment.

This study seeks to address this issue by conducting a randomized controlled trial of a brief conversation to improve opioid safety among Veteran patients receiving long-term opioid therapy. Veterans receiving opioid therapy for pain in primary care will be recruited and randomized to receive either a single session motivational intervention focused on safe opioid use or an equal attention control condition. The primary hypothesis is that the motivational intervention will improve opioid safety, decrease risk behaviors, aberrant opioid use, and total quantities of opioids prescribed relative to the control condition. Study findings will inform efforts to ensure the safety and well-being of Veteran patients with pain.

Conditions

• Pain
• Drug Overdose
• Opioid Use Disorders

Interventions

BEHAVIORAL

Motivational intervention

The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.

BEHAVIORAL

Psycho-educational control

The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.

OTHER

Long-term opioid therapy informed consent

The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Amy S Bohnert, PhD MHS BA · VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-04

Primary Completion

2020-10-01

Completion

2021-03-31

Countries

• United States

Study Locations