An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term

Study Overview
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Brief Summary
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The purpose of this study (RECOVER-LT) is to better understand the long-term paths of recovery from opioid use disorder (OUD) for an additional 5 year period after the original RECOVER (NCT03604861) study. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social and economic well being will be monitored in order to identify factors associated with recovery from OUD.

Official Title
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Remission From Chronic Opioid Use: Study of Environmental and Socioeconomic Factors on Recovery - Long Term

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Other: Online survey only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who enrolled in the RECOVER study Ability to comply with current study protocol requirements for data collection Provide informed consent Exclusion Criteria: Minors will not be included Prisoners will not be included. If participants become incarcerated during this study, they will not be contacted to complete assessments during their incarceration. If the incarceration ends during the study, they may be contacted to participate in assessments Adults who are not capable of consenting on their own behalf

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals who participated in the RECOVER study<br>Individuals who enrolled in the Remission from Chronic Opioid Use-Studying Environmental and Socio-Economic Factors on Recovery (RECOVER) study. Individuals who received at least one injection in a SUBLOCADE Phase III program were eligible to participate in the original study. | Other: Online survey only<br>* There are no interventions planned for this study. This is an observational study only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence from opioid use | Self-reported 7-day point prevalence of opioid use will be measured approximately every 4 months | Change from baseline after a period of up to 5 years will be reported. | 
| Abstinence from opioid use | Self-reported 30-day point prevalence of opioid use will be measured approximately every 4 months | Change from baseline after a period of up to 5 years will be reported. | 
| Abstinence from opioid use | Self-reported opioid use in the time period since last assessment will be measured approximately every 4 months | Change from baseline after a period of up to 5 years will be reported. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from opioid use disorder (OUD) | Assessment of recovery will include assessment of symptoms of OUD as measured by Subjective Opiate Withdrawal Scale (SOWS). Higher numbers indicate worse outcomes | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years. | 
| Recovery from opioid use disorder (OUD) | Assessment of recovery will include assessment of symptoms of OUD as measured by an Opioid Craving Scale, using a visual analog scale which measures moment opioid craving, craving over the past 7 days and craving if participant was present in a previous drug use environment. Higher numbers indicate worse symptoms of craving. | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life measures-household chaos: CHAOS | Measured by CHAOS, the Confusion, hubbub and order scale-short form. This is a 6-item scale which uses yes-no questions to measure the amount of household disorder. Higher levels of household disorder are associated with worse outcomes. | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Satisfaction with medications received to treat OUD: Medication Satisfaction Questionnaire | Completion of a Medication Satisfaction Questionnaire for those receiving medication to treat OUD | Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Assessment of recovery and treatment | Completion of a Treatment Effectiveness Assessment, a patient-centered instrument for evaluating progress in recovery from addiction. Patients provide both numerical responses and representative details on their substance use, health, lifestyle, and community. | Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Recovery from opioid use disorder (OUD) | Participants will be asked to complete a self-assessment of recovery. Participants will rate their perceived success in recovery qualitatively | Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Assessment of functional impairment | Measured by completion of the Sheehan Disability Scale, which is a 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Scores range from 0-30, and higher scores indicate worse impairment. | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life-depression: Beck Depression Inventory-II | Measured by the Beck Depression Inventory-II which measures characteristic attitudes and symptoms of depression. Scores can range from 0-63 and higher numbers indicate worse symptoms of depression. | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life measures - broad domains: WHOQOL-BREF | Measured by the World Health Organization Quality of Life Assessment - Abbreviated Version(WHOQOL-BREF) which measures physical health, social relationships, psychological health and environment | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life measures-overall: Medical Outcomes Study, Short-Form- 12 (SF-12) | Measured by the 12 Item Short Form Health Survey (SF-12) which assesses mental and physical functioning and overall health-related quality of life over a period of time. | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life measures-pain: Brief Pain Inventory | Measured by the Brief Pain Inventory which rates pain severity | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Quality of life measures-adverse experiences: Holmes-Rahe Life Stress Inventory | Measured by the Holmes-Rahe Life Stress Inventory which lists stressful life events that could contribute to illness. Higher scores indicate an increased susceptibility to stress-related health breakdown | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Number of crimes committed | Participants will complete surveys to identify the number and type of criminal incidents in the time period since last assessment | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Occurrence of overdose | Participants will complete survey to identify if an overdose occurred and the number of times of an overdose in the time period since last assessment | Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years | 
| Hospitalization and urgent care utilization | Participants will complete survey to identify if hospitals and emergency room visits occurred and the frequency of visits to the hospitals and emergency rooms in the time period since last assessment | Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years |