The OPT-IN Project
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03526380|
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : February 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders||Behavioral: Behavioral: the OPT-IN Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Translation of Opiate Overdose Prevention Strategies|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Participants receive the OPT-IN Brief Intervention.
Behavioral: Behavioral: the OPT-IN Intervention
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.
No Intervention: Control
Participants will only complete the baseline and follow-up surveys.
- Overdose Risk Behaviors (ORB) [ Time Frame: 3 months post-baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526380
|Contact: Laura C Thomas, MSW/MPHfirstname.lastname@example.org|
|Contact: Erin E Bonar, PhDemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Laura Thomas, MSW/MPH 734-615-4223|
|Principal Investigator: Erin Bonar, PhD|
|Principal Investigator: Amy Bohnert, PhD|