Study Stopped
Study re-scoped due to COVID-19 pandemic.
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
1 other identifier
observational
216
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedStudy Start
First participant enrolled
September 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2021
CompletedOctober 7, 2022
October 1, 2022
4 months
September 18, 2020
October 5, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (15)
Recovery from opioid use disorder (OUD)
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)
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
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
Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Assessment of recovery and treatment
Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
- +10 more secondary outcomes
Study Arms (1)
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.
Interventions
There are no interventions planned for this study. This is an observational study only.
Eligibility Criteria
Participants will be selected from individuals who enrolled in the RECOVER study
You may qualify if:
- Individuals who enrolled in the RECOVER study
- Ability to comply with current study protocol requirements for data collection
- Provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indivior Inc.lead
Study Sites (1)
Addiction Recovery Research Center and Fralin Biomedical Research Institute
Roanoke, Virginia, 24016, United States
Related Publications (2)
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.
PMID: 35287034RESULTKeith 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.
PMID: 37267169DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren Bickel
Virginia Tech Carilion
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2020
First Posted
October 6, 2020
Study Start
September 20, 2020
Primary Completion
January 11, 2021
Study Completion
January 11, 2021
Last Updated
October 7, 2022
Record last verified: 2022-10