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

Indivior Inc.216 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

216

Conditions

Opioid Use Disorder

Interventions

Online survey onlyOTHER

There are no interventions planned for this study. This is an observational study only.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Addiction Recovery Research Center and Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Abstinence from opioid use

Self-reported 7-day point prevalence of opioid use will be measured approximately every 4 months

Time frame: 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

Time frame: 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

Time frame: Change from baseline after a period of up to 5 years will be reported.

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years