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

NCT ID: NCT04577144

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-20

Study Completion Date

2021-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Online survey only

Intervention Type OTHER

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

Interventions

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Online survey only

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indivior Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warren Bickel

Role: PRINCIPAL_INVESTIGATOR

Virginia Tech Carilion

Locations

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Addiction Recovery Research Center and Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 35287034 (View on PubMed)

Keith 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.

Reference Type DERIVED
PMID: 37267169 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35287034/

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

Other Identifiers

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INDV-6000-H03

Identifier Type: -

Identifier Source: org_study_id

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