- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788004
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
January 14, 2026 updated by: Jungmeen Kim-Spoon, Virginia Polytechnic Institute and State University
The goals of this study are to provide a scientific understanding of recovery and relapse, as well as to identify novel targets for future relapse prevention interventions.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will characterize long-term trajectories of recovery from alcohol use including the associated changes in psychosocial functioning and relapse status.
By using an accelerated longitudinal design, competing neurobehavioral decision systems (CNDS) functioning (measured using delay discounting), psychosocial functioning, and relapse will be characterized over a 12-year period for individuals in alcohol use disorder (AUD) recovery.
Study Type
Observational
Enrollment (Actual)
733
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at VTC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals in recovery from AUD who meets the study inclusion criteria will be recruited from The International Quit & Recovery Registry (IQRR) (https://quitandrecovery.org).
Participants will be recruited from existing or new IQRR registrants; that is, IQRR registrants meeting the inclusion criteria (see above) will be invited to participate.
Also, the recruitment of new registrants will use methods designed to reflect the heterogeneity of the recovery population.
Description
Inclusion Criteria:
- be ≥18 yrs old
- meet lifetime DSM-5 AUD criteria
- have a Recovery Initiation Date less than 10 years prior to the time of enrollment
- be able to read independently
- be free of legal problems that could limit participation
- reside in the U.S.
- anticipate continued Internet access (to ensure ongoing contact and data collection)
- be a registrant of the International Quit and Recovery Registry (IQRR)
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 incarcerations ends during the study, they may be contacted to participate in assessments.
- Adults who are not capable of consenting on their own behalf
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort 1
Participants in this group started their recovery process < 1 year ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 2
Participants in this group started their recovery process 1 to <2 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 3
Participants in this group started their recovery process 2 to <3 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 4
Participants in this group started their recovery process 3 to <4 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 5
Participants in this group started their recovery process 4 to <5 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 6
Participants in this group started their recovery process 5 to <6 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 7
Participants in this group started their recovery process 6 to <7 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 8
Participants in this group started their recovery process 7 to <8 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 9
Participants in this group started their recovery process 8 to <9 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
|
Cohort 10
Participants in this group started their recovery process 9 to <10 years ago
|
There are no interventions planned for this study.
This is an observational study only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CNDS functioning
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Delay Discounting (DD) task will be administered to assesses the value of delayed reinforcers.
Participants make hypothetical choices between amounts of delayed and immediate money at various delays (e.g., 1 day to 25 years)
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI)
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
The Psychosocial Functioning Inventory (PFI) will be used to measure social functioning.
The social behavior sub-scale will be calculated from 10 items of the PFI and included items that assess the frequency of problematic social behavior and social interactions in the past 90 days.
The psychosocial functioning scale yields a score ranging from 0-100, with higher scores indicating greater impairment.
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Psychosocial Functioning- World Health Organization (WHO)-Quality of Life
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
WHO-Quality of Life brief assessment (BREF) will be used to measure the four domains of quality of life: (1) physical health; (2) psychological (3) social relationships; and (4) environment (26 items).
Each item in the WHOQOL-BREF will be scored with a 5-point Likert scale (three items are reverse scored), and these scores will be used to generate raw scores for each domain, which will be then scaled 0-100, with higher scores indicating greater quality of life.
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Psychosocial Functioning- Satisfaction with Life and social Functioning
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Satisfaction with life and social functioning over the past 90 days will be assessed using 4 questions: How happy have you been (1) with life?; (2) with your living situation?
and (3) with your relationships? and (4) Did you feel satisfied with leisure, social, and recreational activities?
(0 = satisfied/happy; 1 = dissatisfied/unhappy)
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Psychosocial Functioning- Career Engagement
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Engagement in proactive career behaviors over time (9 items).
Each item in the career engagement measure will be scored with the 5-point Likert-type scale.
The average scale scores will range between 1-5 with higher score indicating greater engagement.
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Psychosocial Functioning- Addiction Severity
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
The Addiction Severity Index (ASI) will be used to assess experiences of serious depression, serious anxiety or tension, and cognitive difficulty (i.e., trouble understanding, concentrating, or remembering) in the past 90 days.
All items will be binary indicators, where 0 = employed or symptom not present and 1 = unemployed or symptom present.
Items will be examined individually.
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Alcohol Use- AUD Status and Severity
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
The Diagnostic and Statistical Manual-5 (DSM-5) AUD (last year & last 3 months) will be used to assess AUD status and severity with mild, moderate, and severe sub-classifications
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Alcohol Use- Consumption
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Timeline Follow Back-90 (TLFB-90) will be used to obtains retrospective daily estimates of alcohol consumption in the last 3 month.
TLFB can generate a variety of variables that provide more precise and varied information (e.g., pattern, variability, drinking levels) about a person's drinking
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
|
Adverse Social and emotional events
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Inventory of Drug Taking Situations (IDTS-8) will be used to assess the frequency of common relapse-inducing events (i.e., negative affect, social pressure, physical discomfort, and drinking-related variables such as temptations, urges, and alcohol cues; 8 items)
|
Approximately every 3 months from date of baseline session through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jungmeen Kim-Spoon, PhD, Virginia Polytechnic Institute and State University
- Principal Investigator: Allison Tegge, PhD, Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2022
Primary Completion (Estimated)
July 20, 2026
Study Completion (Estimated)
July 20, 2026
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IQRR- Longitudinal Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
Technische Universität DresdenCharite University, Berlin, Germany; Central Institute of Mental Health, MannheimRecruitingAlcoholism | Methamphetamine-dependence | Substance Use Disorders | Cocaine Use Disorder | Alcohol Use Disorder (AUD) | Cannabis Use Disorder | Amphetamine Use DisorderGermany
-
Indiana UniversityPatient-Centered Outcomes Research InstituteRecruitingAdolescent | Alcohol Use | Mild Alcohol Use Disorder | Mild Substance Use DisorderUnited States
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
University of BernRecruitingAlcohol Use Disorder (AUD) | Substance Use Disorder (SUD) | Cocaine Use Disorder (CUD)Switzerland
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
University of Wisconsin, MadisonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingAlcohol Use Disorder | Alcohol Use Disorder (AUD)United States
-
Technische Universität DresdenCharite University, Berlin, Germany; Central Institute of Mental Health, MannheimRecruitingAlcoholism | Substance Use Disorders | Alcohol Use Disorder (AUD)Germany
-
University of Notre DameNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use | Opioid Use Disorder | Alcohol Use Disorder | Opioid UseUnited States
Clinical Trials on Online survey
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingGynecologic CancersItaly
-
Hasselt UniversityRecruitingPhysical Activity | Chronic Musculoskeletal Disease | Exercise Intensity | Online SurveyBelgium
-
Virginia Polytechnic Institute and State UniversityWithdrawnSubstance Use Disorders
-
Northwestern UniversityEpidermolysis Bullosa Research PartnershipActive, not recruiting
-
Marmara UniversityCompletedPerception | Restorative Experiences | Esthetic RestorationsTurkey (Türkiye)
-
University Hospital, GhentCompletedQuality of Life | Mental HealthBelgium
-
Universidad Miguel Hernandez de ElchePontificia Universidad Catolica de Chile; University of Sao Paulo; Universidad... and other collaboratorsCompletedAcute Stress DisorderChile, Argentina, Colombia, Ecuador, Spain
-
University of WashingtonCompletedOnline TherapyUnited States
-
Medical University InnsbruckClaudiana LandesfachhochschuleUnknown