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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788004
• Other study ID #: IQRR- Longitudinal Study
• Status: Recruiting
• Start date: September 8, 2022
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Warren K. Bickel, PhD
• Phone: 540-526-2088
• Email: wkbickel[@]vt.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 682
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Other:
• Online survey
There are no interventions planned for this study. This is an observational study only.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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.	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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.	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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)	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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.	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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.	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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	Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary	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)	Approximately every 3 months from date of baseline session through study completion, an average of 3 years