Disclosure Intervention for People in Treatment for Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458985
• Other study ID #: UDISCLOSE RCT
• Secondary ID: R01DA059557
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: June 2024
• Source: University of Delaware
• Contact: Valerie A Earnshaw, PhD
• Phone: 1-302-831-4772
• Email: earnshaw[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Brandywine Counseling & Community Services	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	Brandywine Counseling and Community Services, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment	Whether participants are retained in treatment 1 year after baseline	1 year
Primary	Illicit opioid use	Percentages of drug screens that are positive for illicit opioid use	1 year
Secondary	Recovery capital score	Average scores on recovery capital measure; items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5.	1 year
Secondary	Quality of life score	Average scores on quality of life measure; items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5.	1 year