Disclosure Intervention for People in Recovery From Opioid Use Disorder

Status Completed

Clinical Trial Summary

Many people with substance use disorders struggle with decisions regarding whether to disclose to others that they have a history of substance use and/or are in recovery. Yet, these decisions are important because disclosures can lead to reactions from others that harm or help recovery. For example, stigmatizing responses can harm the mental health of people in recovery whereas supportive responses can strengthen people's commitment to their sobriety. We have developed a brief intervention to help people decide whether and how to tell others about their recovery as well as build skills for disclosure. The purpose of this study is to pilot test this intervention and test its acceptability and feasibility as well as determine if it shows preliminary signs of efficacy in comparison to a control condition. We hypothesize that: (1) participants exposed to the intervention condition will agree that the intervention is acceptable and feasible, and (2) participants in the intervention condition will report higher quality decision making in comparison to participants in the control condition.

Clinical Trial Description

Data will be collected from participants at two time points, spaced one month apart. All participants will be recruited from the waiting room at a local treatment center. The research assistant will screen interested individuals for eligibility in person and schedule study appointments, which may be coordinated with treatment appointments. All study screening and appointments will be conducted in private spaces at the treatment center. At the first study appointment, the research assistant will introduce the study, check for questions, and obtain consent for the study procedures, medical record review, and follow up procedures. Participants will be randomly assigned to receive either the disclosure intervention or a control intervention (i.e., an evidence-based mindfulness intervention). Following the intervention, participants will complete measures of acceptability, feasibility, and decision quality. At the second study appointment, participants will again be asked to respond to survey and interview questions designed to further evaluate the preliminary efficacy of the intervention. In particular, we will investigate whether participants who completed our disclosure intervention report better relationship outcomes than participants who completed the control condition. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04836247
Study type	Interventional
Source	University of Delaware
Contact
Status	Completed
Phase	N/A
Start date	July 26, 2021
Completion date	August 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Enrolling by invitation	`NCT04527926` - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy	N/A
Completed	`NCT04505540` - Start Treatment and Recovery for Opioid Use Disorder	N/A
Completed	`NCT03065049` - Transforming Recovery Through Exercise and Community	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Suspended	`NCT05001789` - Cognitive Functioning in Opioid Use Disorder	N/A
Active, not recruiting	`NCT04650386` - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients	N/A
Completed	`NCT03715634` - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine	Phase 1
Enrolling by invitation	`NCT04991974` - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine	Phase 2/Phase 3
Completed	`NCT04122755` - Single Ascending Dose Study of ALA-1000	Phase 1
Recruiting	`NCT04927143` - Encouraging Abstinence Behavior in a Drug Epidemic	Phase 2
Recruiting	`NCT05049460` - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder	N/A
Recruiting	`NCT05028998` - COVID-19-Related Opioid Treatment Policy Evaluation
Completed	`NCT05047627` - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder	N/A
Active, not recruiting	`NCT04129580` - reSET-O RCT (Randomized Controlled Trial)	N/A
Recruiting	`NCT03923374` - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed	`NCT04464421` - SMART Effectiveness Trial	N/A
Suspended	`NCT02687360` - Imaging the Effects of rTMS on Chronic Pain	N/A
Completed	`NCT04056182` - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.