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

October 5, 2022 updated by: Indivior Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abstinence from opioid use
Time Frame: 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
Change from baseline after a period of up to 5 years will be reported.
Abstinence from opioid use
Time Frame: Change from baseline after a period of up to 5 years will be reported.
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
Time Frame: 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
Change from baseline after a period of up to 5 years will be reported.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recovery from opioid use disorder (OUD)
Time Frame: 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
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)
Time Frame: 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 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
Time Frame: 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.
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
Time Frame: 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
Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Assessment of recovery and treatment
Time Frame: 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.
Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Recovery from opioid use disorder (OUD)
Time Frame: 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
Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Assessment of functional 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
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
Time Frame: 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.
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
Time Frame: 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
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)
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
Hospitalization and urgent care utilization
Time Frame: 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
Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indivior Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Warren Bickel, Virginia Tech Carilion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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