TerminatedNot Applicable

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

Stopped: Study re-scoped due to COVID-19 pandemic.

United States216 participantsStarted 2020-09-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.

Trial details

NCT IDNCT04577144

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-01-11

View on ClinicalTrials.gov More Opioid Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.

Abstinence from opioid use

Timeframe: Change from baseline after a period of up to 5 years will be reported.