SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

NCT ID: NCT04693416

Last Updated: 2023-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2021-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stigma, Social Opioid Use Opioid-use Disorder Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrapersonal Stigma Reduction

The intervention will include education about substance use disorders (diagnosis, prognosis, and treatment), goal setting to assist the individual in preparing for change, and decisional balance to assist the individual in measuring the costs and benefits about disclosure of mental health problems and exercises to practice how to disclose. Facilitation of an intake assessment for treatment will be offered (with assistance in making the appointment, getting transportation and childcare, and securing a pro-bono status at a outpatient treatment facility).

Group Type EXPERIMENTAL

Intrapersonal Stigma Reduction

Intervention Type OTHER

Brief intervention for stigma reduction

Interpersonal Stigma Reduction

The intervention for family members and support persons of enrolled intrapersonal participants will include education about substance use disorders (diagnosis, prognosis, and treatment), stigma reduction, and how to provide support for someone with substance use disorder.

Group Type EXPERIMENTAL

Interpersonal Stigma Reduction

Intervention Type OTHER

Brief intervention for support persons of intrapersonal intervention participants.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrapersonal Stigma Reduction

Brief intervention for stigma reduction

Intervention Type OTHER

Interpersonal Stigma Reduction

Brief intervention for support persons of intrapersonal intervention participants.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older
* Identify as African American, Black, or mixed race
* Identify as someone with a substance use disorder who is not currently in treatment OR a support person of someone enrolled
* Access to a telephone for follow-up assessment
* Reside in the Memphis, TN area

Exclusion Criteria

* Unable to understand consent procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karen Derefinko, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen J Derefinko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: Reliability and validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 2016 May 1;162:34-43. doi: 10.1016/j.drugalcdep.2016.02.019. Epub 2016 Feb 26.

Reference Type BACKGROUND
PMID: 26972790 (View on PubMed)

Palamar JJ. An examination of beliefs and opinions about drug use in relation to personal stigmatization towards drug users. J Psychoactive Drugs. 2013 Nov-Dec;45(5):367-73. doi: 10.1080/02791072.2013.843044.

Reference Type BACKGROUND
PMID: 24592661 (View on PubMed)

Palamar JJ, Kiang MV, Halkitis PN. Development and psychometric evaluation of scales that assess stigma associated with illicit drug users. Subst Use Misuse. 2011;46(12):1457-67. doi: 10.3109/10826084.2011.596606. Epub 2011 Jul 18.

Reference Type BACKGROUND
PMID: 21767076 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3R61AT010604-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-07852

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Peer Support for OUD Recovery
NCT05405712 ACTIVE_NOT_RECRUITING NA
Minds and Mentors Program- R33
NCT05363371 RECRUITING NA
OUD Smartphone Services
NCT06134882 RECRUITING NA