Clinical trial NCT05103514: The Longitudinal Impact of SES and the CNDS on Recovery From SUD
Official title: The Longitudinal Impact of Socioeconomic Status and the Competing Neurobehavioral Decision Systems on Recovery From Substance Use Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Substance Use Disorders
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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).

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.

Eligibility criteria: Inclusion Criteria:

1. be ≥18 yrs old
2. meet lifetime DSM-5 SUD criteria
3. have a Recovery Initiation Date less than 3 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:

1. Minors will not be included
2. 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.
3. Adults who are not capable of consenting on their own behalf

Primary outcomes:
measure: Change in Socioeconomic Status (SES)- Individual Subjective SES
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Socioeconomic Status (SES)- Individual Objective SES
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in CNDS functioning
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI)
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Psychosocial Functioning- World Health Organization (WHO)-Quality of Life
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Psychosocial Functioning- Satisfaction with Life and social Functioning
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Psychosocial Functioning- Career Engagement
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Psychosocial Functioning- Addiction Severity
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Substance Use- SUD Status and Severity
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Change in Substance Use- Consumption
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Warren Bickel, PhD
role: PRINCIPAL_INVESTIGATOR
References: