Disclosure Intervention for People in Treatment for Opioid Use Disorder

Disclosure Intervention to Reduce Social Isolation and Facilitate Recovery Among People in Treatment for Opioid Use Disorder

The goal of this clinical trial is to test a disclosure intervention among people in treatment for opioid use disorder. The main question it aims to answer is whether people who receive a disclosure intervention have better treatment- and recovery-related outcomes one year after receiving the intervention. Participants will complete a brief disclosure intervention designed to help them (1) make key disclosures related to disclosure and (2) build skills to disclose. Researchers will compare results to participants in a waitlist comparator condition, who receive the intervention at the end of the study.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Disclosing Recovery: A Decision Aid and Toolkit

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerie A Earnshaw, PhD; Phone Number: 1-302-831-4772; Email: earnshaw@udel.edu

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19805
      • Recruiting
      • Brandywine Counseling & Community Services
      • Contact: Carly Hill; Phone Number: 1-302-401-1397‬; Email: UDiscloseResearch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Client of Brandywine Counseling & Community Services
• Receiving opioid use disorder treatment at Brandywine Counseling & Community Services
• Considering disclosing one's opioid use disorder history and/or treatment to someone new

Exclusion Criteria:

• Diagnosis of schizophrenia
• Participation in pilot study of intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disclosing Recovery; Participants complete a one-hour disclosure intervention for people in treatment for opioid use disorder. The intervention is facilitated by a workbook and accompanying worksheet.	Behavioral: Disclosing Recovery: A Decision Aid and Toolkit; The Disclosing Recovery intervention is designed to help people in treatment for opioid use disorder (1) make key decisions regarding disclosure, including whether, why, what, how, and when to disclose, and (2) build skills to disclose, including planning what to say, practicing disclosure, and preparing for negative responses.; Other Names: Disclosing Recovery
No Intervention: Waitlist Comparator; Participants do not complete the disclosure intervention at their baseline appointment. They are given the opportunity to complete the disclosure intervention at their final appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in treatment	Whether participants are retained in treatment 1 year after baseline	1 year
Illicit opioid use	Percentages of drug screens that are positive for illicit opioid use	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery capital score	Average scores on recovery capital measure (titled: Brief Assessment of Recovery Capital); items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5. Higher values indicate greater recovery capital.	1 year
Quality of life score	Average scores on quality of life measure (titled: European Health Interview Survey-Quality of Life - 8 item); items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5. Higher scores indicate greater quality of life.	1 year

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institute on Drug Abuse (NIDA); Brandywine Counseling and Community Services

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: disclosure; stigma; social support; social isolation
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: UDISCLOSE RCT; R01DA059557 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from this project will be shared via the National Addiction & HIV Data Archive Program (NAHDAP), which is hosted by the Inter-university Consortium for Political and Social Research (ICPSR). Responses to surveys and medical record data will be shared.
• IPD Sharing Time Frame: Data will be made available no later than when the primary outcome paper is published or when the award ends, whichever comes first. The data will be shared indefinitely.
• IPD Sharing Access Criteria: Data will be accessible through the National Addiction & HIV Data Archive Program (NAHDAP). NAHDAP will make data available via restricted-use files (which will require a signed Restricted Data Use Agreement between the requestor's institution and the University of Michigan as well as an application to request access). ICPSR/NAHDAP will approve or deny access based on the results of the application review.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No