An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
- Conditions
- Opioid Use Disorder
- Interventions
- Other: Online survey only
- Registration Number
- NCT04577144
- Lead Sponsor
- Indivior Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 216
- Individuals who enrolled in the RECOVER study
- Ability to comply with current study protocol requirements for data collection
- Provide informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals who participated in the RECOVER study Online survey only 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.
- Primary Outcome Measures
Name Time Method Abstinence from opioid use Change from baseline after a period of up to 5 years will be reported. Self-reported opioid use in the time period since last assessment will be measured approximately every 4 months
- Secondary Outcome Measures
Name Time Method Recovery from opioid use disorder (OUD) Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years Participants will be asked to complete a self-assessment of recovery. Participants will rate their perceived success in recovery qualitatively
Quality of life measures-household chaos: CHAOS Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years 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.
Quality of life measures - broad domains: WHOQOL-BREF Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years Measured by the World Health Organization Quality of Life Assessment - Abbreviated Version(WHOQOL-BREF) which measures physical health, social relationships, psychological health and environment
Quality of life measures-adverse experiences: Holmes-Rahe Life Stress Inventory Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years 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
Assessment of recovery and treatment Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years 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.
Quality of life-depression: Beck Depression Inventory-II Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years 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.
Quality of life measures-pain: Brief Pain Inventory Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years Measured by the Brief Pain Inventory which rates pain severity
Satisfaction with medications received to treat OUD: Medication Satisfaction Questionnaire Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years Completion of a Medication Satisfaction Questionnaire for those receiving medication to treat OUD
Assessment of functional impairment Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years 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.
Quality of life measures-overall: Medical Outcomes Study, Short-Form- 12 (SF-12) Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years 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.
Occurrence of overdose Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years 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
Hospitalization and urgent care utilization Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years 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
Number of crimes committed Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years Participants will complete surveys to identify the number and type of criminal incidents in the time period since last assessment
Trial Locations
- Locations (1)
Addiction Recovery Research Center and Fralin Biomedical Research Institute
🇺🇸Roanoke, Virginia, United States