N/A
N=299
Primary Care Intervention to Reduce Prescription Opioid Overdoses
Pain · Drug Overdose · Opioid Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02464410 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Overdose Risk Behaviors — 1.31; 1.21; 1.45; 1.25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational intervention (Behavioral); Psycho-educational control (Behavioral); Long-term opioid therapy informed consent (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overdose Risk Behaviors |
1.31; 1.21; 1.45; 1.25; 1.38; 1.07 | — |
| PRIMARY Aberrant Opioid Use |
2.95; 2.51; 2.87; 2.68; 2.80; 2.73 | — |
| PRIMARY Average Number of Days Prescribed Opioid Use Based on Pharmacy Records |
48.23; 45.81; 44.75; 42.54; 42.19; 37.56 | — |
| SECONDARY Number of Participants With Non-fatal Overdose Experiences |
1; 0; 2; 1; 0; 1 | — |
| SECONDARY Treatment Utilization |
1.50; 1.81; 1.61; 2.11; 2.20; 2.04 | — |
| SECONDARY Other (Non-overdose) Injuries From the Revised Injury Behavior Checklist Questionnaire |
5; 4; 4; 5; 11; 4 | — |
| SECONDARY Scores on an Opioid Storage and Disposal Knowledge and Behaviors Questionnaire |
0.95; 0.68; 1.07; 0.69; 1.13; 0.76 | — |
| SECONDARY Level of Oversedation as an Opioid Side Effect |
1.66; 1.96; 1.57; 2.08; 2.36; 2.25 | — |
| SECONDARY General Physical and Mental Functioning From Short Form-12 Questionnaire Scores |
3.57; 3.70; 3.63; 3.76; 3.71; 3.79 | — |
| SECONDARY Pain-specific Disability Score From an Adapted Version of Brief Pain Inventory Questionnaire |
4.86; 5.10; 4.89; 5.16; 4.89; 5.41 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient at the Ann Arbor VA Medical Center receiving treatment in a primary care clinic
- Currently prescribed 20 morphine-equivalent mg (MEM) per day or more of an opioid
- Received opioid therapy for at least 90 days
- 18 years of age or older
Exclusion Criteria
- Plans to stop opioids or reduce dose to below 20 MEM/day in the next 6 months
- Use of fentanyl, due to the difficulty in determining morphine equivalency
- A terminal cancer diagnosis
- Acute suicidality requiring immediate treatment
- Moderately severe cognitive impairment
- Inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT02464410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.