Opioid Use Disorder
Conditions
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.
Interventions
OTHEROnline survey only
There are no interventions planned for this study. This is an observational study only.
Sponsors
Indivior Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence from opioid use | Change from baseline after a period of up to 5 years will be reported. | Self-reported 7-day point prevalence of opioid use will be measured approximately every 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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-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 - 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 |
| Recovery from opioid use disorder (OUD) | Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years. | Assessment of recovery will include assessment of symptoms of OUD as measured by Subjective Opiate Withdrawal Scale (SOWS). Higher numbers indicate worse outcomes |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed