Clinical trial NCT04788004: Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Official title: Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alcohol Use Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 733
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 AUD 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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: CNDS functioning
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: 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: 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: 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: Psychosocial Functioning- Career Engagement
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Psychosocial Functioning- Addiction Severity
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Alcohol Use- AUD Status and Severity
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Alcohol Use- Consumption
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
measure: Adverse Social and emotional events
timeFrame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Jungmeen Kim-Spoon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Polytechnic Institute and State University
name: Allison Tegge, PhD
role: PRINCIPAL_INVESTIGATOR
References: