Opioid Use DisorderRECOVER-LTNCT04577144
An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
An observational study of Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Online survey only
- Type of treatment
- Injection or infusion
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 11 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from individuals who enrolled in the RECOVER study
Who may be able to join
- Individuals who enrolled in the RECOVER study
- Ability to comply with current study protocol requirements for data collection
- Provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Recovery Research Center and Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Online survey only
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online survey onlyOther
There are no interventions planned for this study. This is an observational study only.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online survey only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from opioid use
Self-reported 7-day point prevalence of opioid use will be measured approximately every 4 months
Measured: 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
Measured: 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
Measured: Change from baseline after a period of up to 5 years will be reported.
Secondary outcomes (15)
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
Measured: 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.
Measured: 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.
Measured: 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: 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: 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: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start20 Sep 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Why it stopped: Study re-scoped due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Bickel, Principal investigator, Virginia Tech Carilion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577144
- Sponsor's protocol ID
- INDV-6000-H03
- Acronym
- RECOVER-LT
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35287034Keith 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.
PubMed 37267169
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission From Chronic Opioid Use: Study of Environmental and Socioeconomic Factors on Recovery - Long Term
- ClinicalTrials.gov ID
- NCT04577144
- Acronym / sponsor ID
- RECOVER-LT / INDV-6000-H03
- Conditions
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study re-scoped due to COVID-19 pandemic.
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals who participated in the RECOVER study | – | Other: Online survey onlyIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from individuals who enrolled in the RECOVER study
Key inclusion criteria (3 listed)
- Individuals who enrolled in the RECOVER study
- Ability to comply with current study protocol requirements for data collection
- Provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online survey onlyThere are no interventions planned for this study. This is an observational study only. | Other | Individuals who participated in the RECOVER study |
Primary outcome
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
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
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
15 secondary outcomes
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.
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
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
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
Assessment of recovery and treatment
Time frame: 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
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
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
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
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
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
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
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
Occurrence of overdose
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
Time frame: Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
Results and safety
The study was stopped early (reason given: Study re-scoped due to COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Results publication: PubMed 35287034Craft 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.
- Derived from this study: PubMed 37267169Keith 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.
- Recovery from opioid use disorder: A 4-year post-clinical trial outcomes studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Bickel principal investigator
Virginia Tech Carilion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study re-scoped due to COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence from opioid use (time frame: Change from baseline after a period of up to 5 years will be reported.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.