NCT05103514

Brief Summary

The goal of this study is to provide a scientific understanding of the impact of socioeconomic status (SES) on the recovery trajectory (psychosocial functioning, relapse/remission status, and neurocognitive mechanisms).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
675

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Dec 2025Jul 2028

First Submitted

Initial submission to the registry

October 7, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4.1 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

October 7, 2021

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Change in Socioeconomic Status (SES)- Individual Subjective SES

    Individual Subjective SES will be determined using the MacArthur Scale of subjective social status. Participants will be presented with two social ladders that have 10 steps each and asked to place themselves on the rung that best represent where they stand at this time in their life (1=lowest rung and 10= highest rung), relative to other people in (1) the United States and (2) their community. Higher scores on the 10-rung ladder indicate higher subjective SES.

    Approximately every 3 months from date of baseline session through study completion, an average of 3 years

  • Change in Socioeconomic Status (SES)- Individual Objective SES

    Individual Objective SES will be measured using a composite that was developed by the US Department of Justice (i.e. National Crime Victimization Survey Index 1) that incorporates four main SES elements (i.e., income, education, employment status, and housing tenure measures). Specifically, the SES composite index includes two individual level characteristics: education (possible range: 0-3) and employment in the last 6 months (possible range: 0-1); and two household level characteristics: income as a percentage of the federal poverty level (FPL; possible range: 0-3) and housing tenure (possible range: 0-1). The final SES score (possible range: 0-8) is collapsed into three levels: low (total score of 0 to less than 3), middle (total score of 3 to less than 6), and upper (total score of 6-8) SES.

    Approximately every 3 months from date of baseline session through study completion, an average of 3 years

  • Change in 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

  • Change in 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

  • Change in 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

  • Change in 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

  • Change in 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

  • Change in 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

  • Change in Substance Use- SUD Status and Severity

    The Diagnostic and Statistical Manual-5 (DSM-5) SUD (last year \& last 3 months) will be used to assess SUD 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

  • Change in Substance Use- Consumption

    Timeline Follow Back-90 (TLFB-90) will be used to obtains retrospective daily estimates of substance use in the last 3 month. TLFB can generate a variety of variables that provide more precise and varied information (e.g., pattern, variability) about a person's substance use

    Approximately every 3 months from date of baseline session through study completion, an average of 3 years

Study Arms (3)

Cohort 1

Participants in this group started their recovery process \< 1 year ago

Other: Online Survey

Cohort 2

Participants in this group started their recovery process 1 to \<2 years ago

Other: Online Survey

Cohort 3

Participants in this group started their recovery process 2 to \<3 years ago

Other: Online Survey

Interventions

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals in recovery from SUD 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.

You may qualify if:

  • be ≥18 yrs old
  • meet lifetime DSM-5 SUD criteria
  • have a Recovery Initiation Date less than 3 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)

You may not qualify if:

  • 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 incarceration ends during the study, they may be contacted to participate in assessments.
  • Adults who are not capable of consenting on their own behalf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Warren Bickel, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren K Bickel, PhD

CONTACT

Kirstin M Gatchalian

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 2, 2021

Study Start

December 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share