Substance Use DisordersNCT05103514
The Longitudinal Impact of SES and the CNDS on Recovery From SUD
An observational study of Substance Use Disorders, run by Virginia Polytechnic Institute and State University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Online Survey
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jul 2028
- 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 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.
Who may be able to join
- 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)
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 incarceration ends during the study, they may be contacted to participate in assessments.
- Adults who are not capable of consenting on their own behalf
About this study
Official title: The Longitudinal Impact of Socioeconomic Status and the Competing Neurobehavioral Decision Systems on Recovery From Substance Use Disorder
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).
Read the detailed description
The study will characterize the effect of SES (subjective and objective indicators) on long-term trajectories of recovery and neurocognitive functioning. By using an accelerated longitudinal design, the investigators will examine the association between baseline SES, changes in CNDS, and changes in psychosocial functioning (e.g., quality of life) and relapse. Moreover, the investigators will use computational modeling to capture underlying changes in components of CNDS functioning related to SES and SUD recovery.
- Conditions
- Substance Use Disorders
- Being tested
- Online Survey
- Medical subject headings
- Substance-Related Disorders
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
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 posted2 Nov 2021
- Study start1 Dec 2025 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Why it stopped: proposal not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Warren Bickel, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103514
- Sponsor's protocol ID
- SES- Longitudinal Study
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Impact of Socioeconomic Status and the Competing Neurobehavioral Decision Systems on Recovery From Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05103514
- Acronym / sponsor ID
- SES- Longitudinal Study
- Conditions
- Substance Use Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: proposal not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Nov 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 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).
Detailed description
The study will characterize the effect of SES (subjective and objective indicators) on long-term trajectories of recovery and neurocognitive functioning. By using an accelerated longitudinal design, the investigators will examine the association between baseline SES, changes in CNDS, and changes in psychosocial functioning (e.g., quality of life) and relapse. Moreover, the investigators will use computational modeling to capture underlying changes in components of CNDS functioning related to SES and SUD recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| 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 |
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 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.
Key inclusion criteria (8 listed)
- 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
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 incarceration 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 2, Cohort 3 |
Primary outcome
Change in Socioeconomic Status (SES)- Individual Subjective SES
Time frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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.
Change in Socioeconomic Status (SES)- Individual Objective SES
Time frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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.
Change in 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)
Change in 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.
Change in 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.
Change in 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)
Change in 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.
Change in 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.
Change in Substance Use- SUD 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) SUD (last year \& last 3 months) will be used to assess SUD status and severity with mild, moderate, and severe sub-classifications
Change in Substance 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 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Warren Bickel, PhD principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by Virginia Polytechnic Institute and State University.
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: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Socioeconomic Status (SES)- Individual Subjective SES (time frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years). The study lists 10 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 6 Apr 2026.