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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Warren K. Bickel, PhD
  • Phone Number: 540-526-2088
  • Email: wkbickel@vt.edu

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. be ≥18 yrs old
  2. meet lifetime DSM-5 AUD criteria
  3. have a Recovery Initiation Date less than 10 years prior to the time of enrollment
  4. be able to read independently
  5. be free of legal problems that could limit participation
  6. reside in the U.S.
  7. anticipate continued Internet access (to ensure ongoing contact and data collection)
  8. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Participants in this group started their recovery process < 1 year ago
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
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
Other: Online survey
There are no interventions planned for this study. This is an observational study only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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