The OPT-IN Project
Translation of Opiate Overdose Prevention Strategies
1 other identifier
interventional
92
1 country
1
Brief Summary
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 13, 2020
August 1, 2020
1.7 years
May 3, 2018
August 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overdose Risk Behaviors (ORB)
The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment.
3 months post-baseline
Study Arms (2)
Treatment
EXPERIMENTALParticipants receive the OPT-IN Brief Intervention.
Control
NO INTERVENTIONParticipants will only complete the baseline and follow-up surveys.
Interventions
A private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.
Eligibility Criteria
You may qualify if:
- Speaks English Fluently
- Receiving services at one of the investigator's partner sites
- History of opioid use
You may not qualify if:
- Medically unstable
- Prisoners
- Inability to speak and understand English
- Inability to give informed, voluntary, written consent for any reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Centers for Disease Control and Preventioncollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 16, 2018
Study Start
October 11, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 13, 2020
Record last verified: 2020-08