Disclosure Intervention for Opioid Use Disorder

Overseen By Valerie A Earnshaw, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Schizophrenia, Pilot study participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

480 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Disclosing Recovery: A Decision Aid and Toolkit for opioid use disorder?

Research suggests that personal disclosure of opioid use disorder recovery can improve social support, which is linked to better treatment retention. Additionally, decision aids have been shown to help people with opioid use disorder make informed treatment choices, potentially improving their recovery outcomes. ^{1 2 3 4 5}

Is the Disclosure Intervention for Opioid Use Disorder safe for humans?

The research articles provided do not contain specific safety data for the Disclosure Intervention for Opioid Use Disorder or its related tools. ^{3 6 7 8 9}

How is the treatment 'Disclosing Recovery: A Decision Aid and Toolkit' different from other treatments for opioid use disorder?

This treatment is unique because it focuses on helping individuals with opioid use disorder navigate the process of disclosing their recovery status, which can impact their social support and reduce stigma, unlike traditional treatments that primarily focus on medication or counseling. ^{1 7 10 11 12}

Eligibility Criteria

This trial is for individuals currently in treatment for opioid use disorder at Brandywine Counseling & Community Services, who are considering sharing their history of opioid use or treatment with someone new. It's not open to those diagnosed with schizophrenia or those who participated in the pilot study of this intervention.

Inclusion Criteria

Considering disclosing one's opioid use disorder history and/or treatment to someone new

Client of Brandywine Counseling & Community Services

Receiving opioid use disorder treatment at Brandywine Counseling & Community Services

Exclusion Criteria

I have been diagnosed with schizophrenia.

Participation in pilot study of intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a one-hour disclosure intervention for opioid use disorder, facilitated by a workbook and worksheet

1 hour

1 visit (in-person)

Waitlist Comparator

Participants in the waitlist group do not receive the intervention initially but are given the opportunity to complete it at the end of the study

1 year

Follow-up

Participants are monitored for treatment retention, illicit opioid use, quality of life, and recovery capital over one year

1 year

Treatment Details

Interventions

• Disclosing Recovery: A Decision Aid and Toolkit

Trial Overview The trial tests a 'disclosure intervention' designed to help participants disclose their opioid use disorder and build related skills. Outcomes will be compared against a waitlist group, who'll receive the intervention after the study concludes.

Participant Groups

Group I: Disclosing Recovery Experimental Treatment 1 Intervention

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.

Group II: Waitlist Comparator Active Control 1 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 Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Brandywine Counseling and Community Services

Collaborator

Trials

1

Recruited

480+

Findings from Research

In a study of 146 individuals undergoing treatment for opioid use disorder (OUD), those who had positive disclosure goals (like seeking support and honesty) were more likely to disclose their OUD history within three months and reported greater social support and relationship closeness afterward.

Conversely, individuals with avoidance goals (such as fear of judgment and privacy concerns) experienced more stigma after disclosing their OUD, highlighting the complex impact of personal disclosure on recovery and relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disclosure processes as predictors of relationship outcomes among people in recovery from opioid use disorder: A longitudinal analysis. Earnshaw, VA., Sepucha, KR., Laurenceau, JP., et al.[2021]

Shared Decision Making (SDM) is an important approach for improving patient engagement and satisfaction in acute pain management, especially for patients with a history of opioid use disorder (OUD), but its application in this context is still under-researched.

The review identified key themes affecting SDM in acute pain management for OUD patients, including stigma, the importance of trust and information sharing, the need for clinical tools, and the benefits of interprofessional collaboration, highlighting areas for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Acute Pain Management in Patients with Opioid Use Disorder: A Scoping Review. Vu, PD., Malik, A., Cohen, AS., et al.[2023]

The Patient Decision Aid for Medication Treatment for Opioid Use Disorder (PtDA-MOUD) was developed with input from experts and patients, and it effectively provided information to help patients make informed treatment decisions during their initial clinical visit.

In a pilot test with 36 patients, those who used the PtDA-MOUD were more likely to start medication treatment for opioid use disorder (37% vs. 11% in controls) and received treatment for more days on average, suggesting that the decision aid may enhance treatment initiation and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. Mooney, LJ., Valdez, J., Cousins, SJ., et al.[2021]

A study involving 225 participants from medication-assisted treatment (MAT) programs in West Virginia highlighted that most individuals currently in MAT prefer personalized treatment plans and shared decision-making with their healthcare providers.

Participants expressed mixed opinions on policies regarding the duration of MAT, use of marijuana or anti-anxiety medications during treatment, and attendance in peer recovery groups, indicating the need for flexible and individualized approaches to support retention in MAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. Carter, M., Boyd, J., Bennett, T., et al.[2023]

A shared decision-making aid was developed for pregnant women with opioid use disorder (OUD), and after using it, 95% of participants (21 out of 22) chose to either continue or taper their pharmacotherapy, indicating high engagement in their treatment decisions.

The majority of participants felt well-informed and that their choices aligned with their personal values, with 96% reporting sufficient information and 77%-91% feeling their decisions reflected their preferences, demonstrating the aid's effectiveness in supporting informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision-Making Tool for Treatment of Perinatal Opioid Use Disorder. Guille, C., Jones, HE., Abuhamad, A., et al.[2022]

A new educational tool called 'Le QUIZZ à moindre risque' was developed to help opiate users better understand and manage their addiction, featuring 51 questions focused on risk reduction and substitution drugs.

The tool aims to empower patients by improving their autonomy in health management and enhancing communication with caregivers, and it is currently being tested in various cities in Normandy to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a targeted educational activity in addictology: From design to use in specialized structures in the Normandy region]. Fresnaye, J., Le Pennec, A., Fouques, C., et al.[2023]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The TLFB (Timeline Follow-Back) questionnaire developed for the REBOOT study was found to be a feasible and acceptable method for assessing opioid use and non-fatal overdoses among 174 opioid overdose survivors over a 16-month period.

Out of 525 assessments, 88% of participants reported that the TLFB was very or somewhat acceptable, indicating that this method can effectively gather important data on opioid use and treatment experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a timeline follow-back method to assess opioid use, non-fatal overdose, and substance use disorder treatment. McCann, NC., McMahan, VM., Smith, R., et al.[2023]

Recovery residences (RRs) can significantly enhance recovery for individuals with opioid use disorder (OUD) by providing social support and fostering community, but they often do not fully support the use of opioid agonist and antagonist medications.

Barriers such as stigma and inadequate training for staff limit the effectiveness of RRs in supporting medication-assisted recovery, highlighting the need for workforce development and further research to improve practices and outcomes for residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting individuals using medications for opioid use disorder in recovery residences: challenges and opportunities for addressing the opioid epidemic. Miles, J., Howell, J., Sheridan, D., et al.[2021]

The Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T) showed a moderate effect on improving treatment retention for opioid-dependent adults, particularly when the concerned significant other was a parent, where it had a significant impact (p<0.01).

CRAFT-T also significantly reduced opioid and other drug use among participants, indicating its potential efficacy as a treatment intervention for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Brigham, GS., Slesnick, N., Winhusen, TM., et al.[2021]

Patients receiving methadone treatment reported experiencing various forms of stigma related to substance use and medication, which significantly hindered their retention in opioid use disorder treatment programs.

Peer recovery specialists (PRSs), who share similar experiences with substance use and recovery, have the potential to reduce stigma and improve retention in medication for opioid use disorder by leveraging their unique perspectives and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. Anvari, MS., Kleinman, MB., Massey, EC., et al.[2023]

The Social Network Activation Group, designed for opioid-dependent patients, showed preliminary feasibility with 66 participants attending 71% of sessions and engaging in community activities to recruit drug-free support for their recovery.

About 36% of participants successfully introduced a drug-free family member or friend to their counselor, indicating that many patients have supportive individuals willing to help in their recovery journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobilizing community support in people receiving opioid-agonist treatment: A group approach. Kidorf, M., Brooner, RK., Peirce, J., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Disclosure processes as predictors of relationship outcomes among people in recovery from opioid use disorder: A longitudinal analysis. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Acute Pain Management in Patients with Opioid Use Disorder: A Scoping Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Shared Decision-Making Tool for Treatment of Perinatal Opioid Use Disorder. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Development of a targeted educational activity in addictology: From design to use in specialized structures in the Normandy region]. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a timeline follow-back method to assess opioid use, non-fatal overdose, and substance use disorder treatment. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Supporting individuals using medications for opioid use disorder in recovery residences: challenges and opportunities for addressing the opioid epidemic. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Mobilizing community support in people receiving opioid-agonist treatment: A group approach. [2019]