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Study re-scoped due to COVID-19 pandemic.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals who participated in the RECOVER study | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online survey only | Other | There are no interventions planned for this study. This is an observational study only. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be selected from individuals who enrolled in the RECOVER study
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| Name | Affiliation | Role |
|---|---|---|
| Warren Bickel | Virginia Tech Carilion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addiction Recovery Research Center and Fralin Biomedical Research Institute | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35287034 | Result | Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9. | |
| 37267169 | Derived |
| Label | URL |
|---|---|
| Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study | View source |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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 |
| Keith DR, Tegge AN, Stein JS, Athamneh LN, Craft WH, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Struggling With Recovery From Opioids: Who Is at Risk During COVID-19? J Addict Med. 2023 May-Jun 01;17(3):e156-e163. doi: 10.1097/ADM.0000000000001096. Epub 2022 Oct 16. |