An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term (RECOVER-LT)

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

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 Overview

• Status: Terminated
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Other: Online survey only

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Addiction Recovery Research Center and Fralin Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from individuals who enrolled in the RECOVER study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Online survey only; There are no interventions planned for this study. This is an observational study only.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indivior Inc.
• Investigators: Principal Investigator: Warren Bickel, Virginia Tech Carilion

Publications and helpful links

General Publications

• 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. Erratum In: Drug Alcohol Depend. 2022 Dec 1;241:109687.

Helpful Links

• Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: INDV-6000-H03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No