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OpenTrials
Active, Not Recruiting

NCT Number: NCT04788004

Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online survey

Other

There are no interventions planned for this study. This is an observational study only.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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)

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2021
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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