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

Opioid Use Disorder Clinical Trial

— RECOVER-LT  

Official title:

Remission From Chronic Opioid Use: Study of Environmental and Socioeconomic Factors on Recovery - Long Term

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04577144
• Other study ID #: INDV-6000-H03
• Status: Terminated
• Start date: September 20, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: October 2022
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 216
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Online survey only
There are no interventions planned for this study. This is an observational study only.

Locations

Country	Name	City	State
United States	Addiction Recovery Research Center and Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Recovery from opioid use disorder (OUD)	Assessment of recovery will include assessment of symptoms of OUD as measured by Subjective Opiate Withdrawal Scale (SOWS). Higher numbers indicate worse outcomes	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years.
Secondary	Recovery from opioid use disorder (OUD)	Assessment of recovery will include assessment of symptoms of OUD as measured by an Opioid Craving Scale, using a visual analog scale which measures moment opioid craving, craving over the past 7 days and craving if participant was present in a previous drug use environment. Higher numbers indicate worse symptoms of craving.	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life measures-household chaos: CHAOS	Measured by CHAOS, the Confusion, hubbub and order scale-short form. This is a 6-item scale which uses yes-no questions to measure the amount of household disorder. Higher levels of household disorder are associated with worse outcomes.	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Satisfaction with medications received to treat OUD: Medication Satisfaction Questionnaire	Completion of a Medication Satisfaction Questionnaire for those receiving medication to treat OUD	Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Assessment of recovery and treatment	Completion of a Treatment Effectiveness Assessment, a patient-centered instrument for evaluating progress in recovery from addiction. Patients provide both numerical responses and representative details on their substance use, health, lifestyle, and community.	Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Recovery from opioid use disorder (OUD)	Participants will be asked to complete a self-assessment of recovery. Participants will rate their perceived success in recovery qualitatively	Measured annually from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Assessment of functional impairment	Measured by completion of the Sheehan Disability Scale, which is a 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Scores range from 0-30, and higher scores indicate worse impairment.	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life-depression: Beck Depression Inventory-II	Measured by the Beck Depression Inventory-II which measures characteristic attitudes and symptoms of depression. Scores can range from 0-63 and higher numbers indicate worse symptoms of depression.	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life measures - broad domains: WHOQOL-BREF	Measured by the World Health Organization Quality of Life Assessment - Abbreviated Version(WHOQOL-BREF) which measures physical health, social relationships, psychological health and environment	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life measures-overall: Medical Outcomes Study, Short-Form- 12 (SF-12)	Measured by the 12 Item Short Form Health Survey (SF-12) which assesses mental and physical functioning and overall health-related quality of life over a period of time.	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life measures-pain: Brief Pain Inventory	Measured by the Brief Pain Inventory which rates pain severity	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Quality of life measures-adverse experiences: Holmes-Rahe Life Stress Inventory	Measured by the Holmes-Rahe Life Stress Inventory which lists stressful life events that could contribute to illness. Higher scores indicate an increased susceptibility to stress-related health breakdown	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Number of crimes committed	Participants will complete surveys to identify the number and type of criminal incidents in the time period since last assessment	Up to 14 assessments approximately every 4 months from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Occurrence of overdose	Participants will complete survey to identify if an overdose occurred and the number of times of an overdose in the time period since last assessment	Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years
Secondary	Hospitalization and urgent care utilization	Participants will complete survey to identify if hospitals and emergency room visits occurred and the frequency of visits to the hospitals and emergency rooms in the time period since last assessment	Up to 14 assessments from Assessment 1 to Assessment 14 over a period of up to 5 years

External Links

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