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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. Identifier: NCT03526380
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : February 26, 2019
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Amy S.B. Bohnert, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Behavioral: Behavioral: the OPT-IN Intervention Not Applicable

Detailed Description:
Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
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

Arm Intervention/treatment
Experimental: Treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Speaks English Fluently
  • Receiving services at one of the investigator's partner sites
  • History of opioid use

Exclusion Criteria:

  • Medically unstable
  • Prisoners
  • Inability to speak and understand English
  • Inability to give informed, voluntary, written consent for any reason

Information from the National Library of Medicine

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 identifier (NCT number): NCT03526380

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Contact: Laura C Thomas, MSW/MPH 734-615-4223
Contact: Erin E Bonar, PhD

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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         
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention

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Responsible Party: Amy S.B. Bohnert, Associate Professor, University of Michigan Identifier: NCT03526380     History of Changes
Other Study ID Numbers: R49CE002099 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy S.B. Bohnert, University of Michigan:
Drug overdose
Substance-Related Disorders
Chemically-Induced Disorders
Risk Reduction Behavior
Harm Reduction
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders