Disclosure Intervention for People in Treatment for Opioid Use Disorder

NCT06458985 | Recruiting DMC

• 2 other identifiers: UDISCLOSE RCTR01DA059557
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

disclosure; social isolation; stigma; social support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Recovery capital score

  1 year

• Quality of life score

  1 year

Study Arms (2)

Disclosing Recovery

EXPERIMENTAL

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

Waitlist Comparator

NO INTERVENTION

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.

Interventions

Disclosing Recovery: A Decision Aid and Toolkit BEHAVIORAL

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.

Also known as: Disclosing Recovery

Disclosing Recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of schizophrenia
• Participation in pilot study of intervention

Sponsors & Collaborators

• University of Delaware: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Brandywine Counseling and Community Services: collaborator

Study Sites (1)

Brandywine Counseling & Community Services

Wilmington, Delaware, 19805, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Social Isolation; Social Stigma

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Central Study Contacts

Valerie A Earnshaw, PhD

CONTACT

1-302-831-4772; earnshaw@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)