Barriers to Substance Use Disorder Recovery

October 31, 2024 updated by: Prerana Roth, Prisma Health-Upstate
The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million Americans each year. The life-altering consequences of SUD are both diverse and severe, influencing mortality, the workplace, and economics. The goal of this study is to determine how specific risk factors of relapse and barriers to recovery, including neurocognitive, health, personal, social, financial, and situational barriers, can be overcome or changed through a recovery coaching intervention. This work seeks to provide a mechanism to demonstrate exactly how and why this potential new model of care (recovery coaching) is effective, rather than simply assessing if it can work. To accomplish this aim, the change between baseline and 6-month assessments will be assessed. Then, the difference in the change between individuals assigned to the current standard of care and patients assigned to inpatient recovery will be compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 - 60
  • English speaking;
  • Identified by healthcare provider as having Substance Use Disorder
  • Recent substance use
  • Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital

Exclusion Criteria:

  • Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
  • Are admitted for marijuana use only
  • Are admitted for cocaine use only
  • Are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care Control
Patients in the control condition receive the current standard of care, which entails a treatment referral with a list of addiction recovery facilities, groups, and resources. It is the patient's responsibility to call a treatment facility or group on the list and thus relies on self-referral. The medical team is not permitted to call a facility or group on behalf of the patient. The physician may counsel the patient on the dangers of substance abuse and addiction, but the extent of counseling is variable and dependent on the individual physician.
Experimental: Recovery Coach Intervention

Experimental: Recovery Coach Intervention Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR)

- Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
Behavioral: Recovery Coach Intervention
Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Social Support
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Participants will complete the 5-item Social Support subscale of the Assessment of Recovery Capital (ARC) to assess social support. The difference between the post-baseline and baseline measures will be assessed.
intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Financial Barriers to SUD Recovery
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
These barriers include lack of stable housing, transportation, and cost of recovery services. Participants will complete the Housing and Safety Subscale of the Assessment of Recovery Capital (ARC) to assess social support and housing stability. The difference between the post-baseline and baseline measures will be assessed.
intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Situational Barriers to SUD Recovery
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
The barriers measured will be (1) long delays for treatment, (2) complexity of navigating the healthcare system, (3) lack of programs in one's community, (4)lack of professional help, (4) and not knowing where to go for help. The response options are binary (yes, they think this is a barrier to their recovery', or 'no, not a barrier to recovery'). Responses to these questions (0=no, 1=yes) will be summed to determine situational barriers. The difference between the post-baseline and baseline measures will be assessed.
intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Inhibitory Control
Time Frame: baseline and 6 months post-baseline assessment
Inhibitory control will be assessed behaviorally using a 150 - 200 trial computerized 'Stop Signal' Task, the most common measure of this construct. Stop Signal Reaction Time (SSRT) and Stop trial accuracy will be measured and compared across time points.
baseline and 6 months post-baseline assessment
Change in Resting State EEG beta poewer
Time Frame: baseline and 6 months post-baseline assessment
We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
baseline and 6 months post-baseline assessment
Change in Striatal Dopaminergic Functioning
Time Frame: baseline and 6 months post-baseline assessment
Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
baseline and 6 months post-baseline assessment
Change in Risk-Taking
Time Frame: baseline and 6 months post-baseline assessment
Risk-taking will be measured using the 7-item Risk Propensity Scale (Meertens & Lion, 2008). Higher scores on this scale indicate greater risk-taking propensity.
baseline and 6 months post-baseline assessment
Change in Emotion Regulation
Time Frame: baseline and 6 months post-baseline assessment
The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
baseline and 6 months post-baseline assessment
Change in Goal-Related Activities
Time Frame: baseline and 6 months post-baseline assessment
Participants will complete the 5-item Meaningful Activities from the Assessment of Recovery Capital questionnaire. The 5 items will be summed for a total score.
baseline and 6 months post-baseline assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Engagement in Recovery Services
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Active involvement in recovery programs. This is a binary response question. Participants are asked "Are you actively involved in a recovery program right now?". Response options are 'yes' or 'no'. We will measure the change over time in engagement for each participant and compare the percentage of those in the intervention and control arm that are actively involved in recovery services at each time point.
intervals of 1, 2, 3, and 6 months post-baseline assessment
Hospital Visit Frequency
Time Frame: six months pre- and post-baseline assessment
number of readmissions and number of emergency department visits
six months pre- and post-baseline assessment
Substance Use Severity
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Frequency of substance use in past 30 days measured using the Addiction Severity Index (ASI-Lite).
intervals of 1, 2, 3, and 6 months post-baseline assessment
Emotional Well-being
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Participants will be asked to self-report two items about their emotion well-being on a scale of 0 (Not at all) to 9 (Severely). The questions are "In the past 30 days, how much have you been bothered by feeling sad, down, or uninterested in life?" and "In the past 30-days, have you felt anxious or nervous?".
intervals of 1, 2, 3, and 6 months post-baseline assessment
Life Satisfaction
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Participants will be asked to self-report their life satisfaction using a single item question on a scale of 1 (Very Satisfied) to 4 (Very Dissatisfied). Change across time on this scale will be measured.
intervals of 1, 2, 3, and 6 months post-baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prisma Health-Upstate

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
Clemson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00087080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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