Barriers to Substance Use Disorder Recovery

Substance Use Disorders Clinical Trial

Official title:

Barriers to Substance Use Disorder Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098614
• Other study ID #: Pro00087080
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: December 18, 2020

Study information

• Verified date: February 2021
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Greenville Memorial Hospital	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University, University of South Carolina School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Social Support	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
Primary	Change in Financial Barriers to SUD Recovery	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
Primary	Change in Situational Barriers to SUD Recovery	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
Primary	Change in Inhibitory Control	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
Primary	Change in Resting State EEG beta poewer	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
Primary	Change in Striatal Dopaminergic Functioning	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
Primary	Change in Risk-Taking	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
Primary	Change in Emotion Regulation	The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.	baseline and 6 months post-baseline assessment
Primary	Change in Goal-Related Activities	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	Engagement in Recovery Services	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
Secondary	Hospital Visit Frequency	number of readmissions and number of emergency department visits	six months pre- and post-baseline assessment
Secondary	Substance Use Severity	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
Secondary	Emotional Well-being	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
Secondary	Life Satisfaction	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