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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06458985
Other study ID # UDISCLOSE RCT
Secondary ID R01DA059557
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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