Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04577144
Other study ID # INDV-6000-H03
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06021431 - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT N/A
Completed NCT06266572 - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment Phase 1
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT06200740 - Remotely Observed Methadone Evaluation N/A
Not yet recruiting NCT06441604 - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy Phase 2
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Completed NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder Phase 1
Completed NCT02440256 - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT05587998 - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users. Phase 1
Recruiting NCT06001437 - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT05546229 - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting NCT06416020 - Integrating MOUD in African American Community Settings (Better Together) N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Recruiting NCT06206291 - Cannabidiol for Opioid Addiction Phase 2
Completed NCT05552040 - START NOW in the Treatment of Opioid Addicted Individuals N/A
Recruiting NCT05459922 - Adjunctive Bright Light Therapy for Opioid Use Disorder N/A
Recruiting NCT05343169 - Community-based Education, Navigation, and Support Intervention for Military Veterans N/A
Recruiting NCT06081985 - Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder N/A