Alcohol Use DisorderNCT04788004
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
An observational study of Alcohol Use Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Online survey
- How many people
- 733 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 14 Jul 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Online survey
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
There are no interventions planned for this study. This is an observational study only.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants in this group started their recovery process < 1 year ago Receives: Other: Online survey | |
| Cohort 2 | Participants in this group started their recovery process 1 to <2 years ago Receives: Other: Online survey | |
| Cohort 3 | Participants in this group started their recovery process 2 to <3 years ago Receives: Other: Online survey | |
| Cohort 4 | Participants in this group started their recovery process 3 to <4 years ago Receives: Other: Online survey | |
| Cohort 5 | Participants in this group started their recovery process 4 to <5 years ago Receives: Other: Online survey | |
| Cohort 6 | Participants in this group started their recovery process 5 to <6 years ago Receives: Other: Online survey | |
| Cohort 7 | Participants in this group started their recovery process 6 to <7 years ago Receives: Other: Online survey | |
| Cohort 8 | Participants in this group started their recovery process 7 to <8 years ago Receives: Other: Online survey | |
| Cohort 9 | Participants in this group started their recovery process 8 to <9 years ago Receives: Other: Online survey | |
| Cohort 10 | Participants in this group started their recovery process 9 to <10 years ago Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNDS functioning
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)
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI)
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.
Measured: 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
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.
Measured: 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
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)
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Psychosocial Functioning- Career Engagement
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.
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Psychosocial Functioning- Addiction Severity
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.
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Alcohol Use- AUD Status and Severity
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
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Alcohol Use- Consumption
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
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Adverse Social and emotional events
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)
Measured: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start8 Sep 2022
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 733 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jungmeen Kim-Spoon, Virginia Polytechnic Institute and State University
- Investigators
- Jungmeen Kim-Spoon, PhD, Principal investigator, Virginia Polytechnic Institute and State UniversityAllison Tegge, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788004
- Sponsor's protocol ID
- IQRR- Longitudinal Study
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
- ClinicalTrials.gov ID
- NCT04788004
- Acronym / sponsor ID
- IQRR- Longitudinal Study
- Conditions
- Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Online surveyParticipants in this group started their recovery process < 1 year ago |
| Cohort 2 | – | Other: Online surveyParticipants in this group started their recovery process 1 to <2 years ago |
| Cohort 3 | – | Other: Online surveyParticipants in this group started their recovery process 2 to <3 years ago |
| Cohort 4 | – | Other: Online surveyParticipants in this group started their recovery process 3 to <4 years ago |
| Cohort 5 | – | Other: Online surveyParticipants in this group started their recovery process 4 to <5 years ago |
| Cohort 6 | – | Other: Online surveyParticipants in this group started their recovery process 5 to <6 years ago |
| Cohort 7 | – | Other: Online surveyParticipants in this group started their recovery process 6 to <7 years ago |
| Cohort 8 | – | Other: Online surveyParticipants in this group started their recovery process 7 to <8 years ago |
| Cohort 9 | – | Other: Online surveyParticipants in this group started their recovery process 8 to <9 years ago |
| Cohort 10 | – | Other: Online surveyParticipants in this group started their recovery process 9 to <10 years ago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online surveyThere are no interventions planned for this study. This is an observational study only. | Other | Cohort 1, Cohort 10, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
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)
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.
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.
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)
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.
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.
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jungmeen Kim-Spoon, PhD principal investigator
Virginia Polytechnic Institute and State University
Allison Tegge, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNDS functioning (time frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.