Opioid Use DisorderNCT06458985
Disclosure Intervention for People in Treatment for Opioid Use Disorder
A study testing Disclosing Recovery: A Decision Aid and Toolkit in people with Opioid Use Disorder, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Disclosing Recovery: A Decision Aid and Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of schizophrenia
- Participation in pilot study of intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brandywine Counseling & Community Services
Wilmington, Delaware, 19805
Carly Hill, 1-302-401-1397, UDiscloseResearch@gmail.com
About this study
Official title: 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Disclosing Recovery: A Decision Aid and Toolkit
- Keywords
- disclosure, social isolation, stigma, social support
- Medical subject headings
- Opioid-Related Disorders, Social Isolation, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosing Recovery: A Decision Aid and ToolkitBehavioural
Also called Disclosing Recovery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Whether participants are retained in treatment 1 year after baseline
Measured: 1 year
Illicit opioid use
Percentages of drug screens that are positive for illicit opioid use
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 May 2024
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Brandywine Counseling and Community Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458985
- Sponsor's protocol ID
- UDISCLOSE RCT
- Other IDs
- R01DA059557
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosure Intervention to Reduce Social Isolation and Facilitate Recovery Among People in Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06458985
- Acronym / sponsor ID
- UDISCLOSE RCT
- Conditions
- Opioid Use Disorder
- Keywords
- disclosure, social isolation, stigma, social support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Brandywine Counseling and Community Services
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disclosing Recovery | Experimental | Behavioral: Disclosing Recovery: A Decision Aid and ToolkitParticipants complete a one-hour disclosure intervention for people in treatment for opioid use disorder. The intervention is facilitated by a workbook and accompanying worksheet. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of schizophrenia
- Participation in pilot study of intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosing Recovery: A Decision Aid and ToolkitAlso: Disclosing RecoveryThe 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. | Behavioural | Disclosing Recovery |
Primary outcome
Retention in treatment
Time frame: 1 year
Whether participants are retained in treatment 1 year after baseline
Illicit opioid use
Time frame: 1 year
Percentages of drug screens that are positive for illicit opioid use
2 secondary outcomes
Recovery capital score
Time frame: 1 year
Quality of life score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosing Recovery: A Decision Aid and Toolkit in people with Opioid Use Disorder, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie A Earnshaw, PhD (1-302-831-4772, earnshaw@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.