Clinical trial NCT04577144: An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Official title: Remission From Chronic Opioid Use: Study of Environmental and Socioeconomic Factors on Recovery - Long Term
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Opioid Use Disorder
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from individuals who enrolled in the RECOVER study

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.


Eligibility criteria: 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

Primary outcomes:
measure: Abstinence from opioid use
timeFrame: Change from baseline after a period of up to 5 years will be reported.
measure: Abstinence from opioid use
timeFrame: Change from baseline after a period of up to 5 years will be reported.
measure: Abstinence from opioid use
timeFrame: Change from baseline after a period of up to 5 years will be reported.
Secondary outcomes:
measure: Recovery from opioid use disorder (OUD)
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years.
measure: Recovery from opioid use disorder (OUD)
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life measures-household chaos: CHAOS
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Satisfaction with medications received to treat OUD: Medication Satisfaction Questionnaire
timeFrame: Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Assessment of recovery and treatment
timeFrame: Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Recovery from opioid use disorder (OUD)
timeFrame: Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Assessment of functional impairment
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life-depression: Beck Depression Inventory-II
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life measures - broad domains: WHOQOL-BREF
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life measures-overall: Medical Outcomes Study, Short-Form- 12 (SF-12)
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life measures-pain: Brief Pain Inventory
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Quality of life measures-adverse experiences: Holmes-Rahe Life Stress Inventory
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Number of crimes committed
timeFrame: Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Occurrence of overdose
timeFrame: Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
measure: Hospitalization and urgent care utilization
timeFrame: Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Addiction Recovery Research Center and Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Virginia Tech Carilion
name: Warren Bickel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.