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NCT Number: NCT03604861

An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003).

The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.

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Key information

Conditions

Opioid-use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Heroin Dependence Impulsive Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Winston Technology Research LLC, Haleyville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who received at least one injection in RBP-6000 or placebo in the Phase III clinical program which includes study protocols NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) and either withdrew from or completed these studies.
  • Ability to comply with study protocol requirements for data collection and provide informed consent.

Treatment and study plan

Not applicable - no defined intervention

Other

Participants who received at least one injection of RBP-6000 or placebo and either withdrew from or completed the Phase III clinical program which included studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) were eligible for the RECOVER Study.

Primary outcomes

  1. Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24

    Time frame: Month 24

    Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).

  2. Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days At Months 3, 6, 9, 12, 15, 18, 21, 24

    Time frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24

    Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).

  3. Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 28 Days At Months 3, 6, 9, 12, 15, 18, 21, 24

    Time frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24

    Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).

  4. Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24

    Time frame: Month 24

    Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.

  5. Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by UDS At Months 3, 6, 9, 12, 15, 18, 21, 24

    Time frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24

    Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.

Other outcomes

  1. Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24

    Time frame: Baseline (Day 1), Months 12 and 24

  2. Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24

    Time frame: Baseline (Day 1), Months 12 and 24

  3. Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24

    Time frame: Baseline (Day 1), Months 12 and 24

  4. Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24

    Time frame: Baseline (Day 1), Months 12 and 24

  5. Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24

    Time frame: Baseline (Day 1), Months 12 and 24

  6. Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24

    Time frame: Months 1-12 and Months 13-24

    HCRU information includes hospitalizations, residential substance abuse treatment, general practitioner/specialist/and counseling visits, and emergency department (ED) visits.

  7. Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24

    Time frame: Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24

    Participants complete surveys to identify the number and type of criminal incidents in a given time frame. These questions include information on arrests, violence, unlawful behaviors, and driver's license status.

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study title

Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®

Acronym: RECOVER®

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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