ClinicalTrials.gg
RecruitingNCT06458985Updated Jul 18, 2025

Disclosure Intervention for People in Treatment for Opioid Use Disorder

An interventional study of Disclosing Recovery: A Decision Aid and Toolkit in Opioid Use Disorder, sponsored by University of Delaware. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by University of Delaware · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • disclosure
  • social isolation
  • stigma
  • social support
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 480 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Diagnosis of schizophrenia
  • Participation in pilot study of intervention
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralDisclosing 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.

    Also known as: Disclosing Recovery

06

What researchers measure

Primary outcomes

  1. Retention in treatment

    Whether participants are retained in treatment 1 year after baseline

    Time frame: 1 year

  2. Illicit opioid use

    Percentages of drug screens that are positive for illicit opioid use

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Brandywine Counseling & Community Services
    Wilmington, Delaware 19805, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458985
Collaborators
National Institute on Drug Abuse (NIDA), Brandywine Counseling and Community Services
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
May 20, 2024
Primary completion
May 1, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Jul 18, 2025

Study contacts

Valerie A Earnshaw, PhD
Contact
earnshaw@udel.edu
1-302-831-4772

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion