- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04098614
Barriers to Substance Use Disorder Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social Support
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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.
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Change in Financial Barriers to SUD Recovery
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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.
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Change in Situational Barriers to SUD Recovery
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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.
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Change in Inhibitory Control
Time Frame: baseline and 6 months post-baseline assessment
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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.
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baseline and 6 months post-baseline assessment
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Change in Resting State EEG beta poewer
Time Frame: baseline and 6 months post-baseline assessment
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We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
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baseline and 6 months post-baseline assessment
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Change in Striatal Dopaminergic Functioning
Time Frame: baseline and 6 months post-baseline assessment
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Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
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baseline and 6 months post-baseline assessment
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Change in Risk-Taking
Time Frame: baseline and 6 months post-baseline assessment
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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.
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baseline and 6 months post-baseline assessment
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Change in Emotion Regulation
Time Frame: baseline and 6 months post-baseline assessment
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The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
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baseline and 6 months post-baseline assessment
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Change in Goal-Related Activities
Time Frame: baseline and 6 months post-baseline assessment
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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.
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baseline and 6 months post-baseline assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement in Recovery Services
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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.
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Hospital Visit Frequency
Time Frame: six months pre- and post-baseline assessment
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number of readmissions and number of emergency department visits
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six months pre- and post-baseline assessment
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Substance Use Severity
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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Frequency of substance use in past 30 days measured using the Addiction Severity Index (ASI-Lite).
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Emotional Well-being
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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?".
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Life Satisfaction
Time Frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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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.
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intervals of 1, 2, 3, and 6 months post-baseline assessment
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00087080
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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