Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03799341
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2019-01-07
Brief Title:
Neurocognitive Factors in Substance Use Treatment Response The Ways of Rewarding Abstinence Project
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Electrophysiological Predictors and Indicators of Contingency Management Treatment Response
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WRAP
Brief Summary:
The proposed work will investigate changes in brain signaling and cognitive functioning that support recovery from addiction as well as use of pretreatment neurocognitive functioning to inform substance use treatment planning Substance use disorders are prevalent amongst Veterans Cocaine addiction in particular has been shown to complicate treatment of other high priority behavioral health problems in the Veteran population eg PTSD opioid addiction While there are currently no approved medications to support recovery from cocaine addiction research indicates that Contingency Management CM - a behavioral intervention for cocaine users - can be effective However individual responses are variable and long-term benefits are limited This CDA will test a new model of how CM works by examining brain-based predictors and indicators of treatment response Results will have immediate implications for measurement-based implementation of existing CM variants within the VA supporting access to the version of CM that is best aligned with each Veterans needs
Detailed Description:
Electrophysiological methods including event-related potential and functional connectivity approaches have potential to clarify mechanisms of substance use treatment response and characterize individual differences therein Veterans are disproportionately affected by disorders of addiction of which cocaine use disorder CUD is particularly problematic due to high relapse rates and the absence of approved pharmacotherapy options Behavioral interventions for CUD have therefore become an important focus and Contingency Management CM has emerged as the best-supported approach CM involves reinforcing cocaine abstinence established through objective testing with reliable short-term reward such as chances to win prizes ie Prize-Based CM or PBCM Given robust empirical support nationwide dissemination of PBCM has been supported by a VHA initiative since 2011 However PBCM response rates are variable and long-term benefits are limited - problems magnified by the cost of implementation with respect to staffing and prizes Measurement-based approaches to PBCM implementation have promise to improve the effectiveness and efficiency of CM programming but have not yet been investigated within the VA or considered in relation to promising neuromarkers Importantly two versions of PBCM are already utilized at VA sites and may differentially benefit individuals with distinct neurocognitive profiles Specifically VA PBCM programs employ either abstract voucher prize or concrete tangible prize incentives the latter of which may more effectively incentivize abstinence in Veterans with poor future-oriented thinking and planning ability While selection between existing PBCM variants currently reflects practical considerations only pretreatment neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this regard
This project aims to advance measurement-based implementation of CM by testing a novel neurocognitive model with immediate implications for the use of abstract versus concrete PBCM incentives within the VA Specifically the future-minded decision-making FMDM model posits that CM scaffolds future-oriented goal representation and self-control to support abstinence during in the moment use-related decision-making For individuals with greater FMDM impairment concrete readily-accessible incentives may be more effective than abstract voucher-based rewards which require future-oriented thinking and planning to acquire value To test this model neurocognitive substrates of FMDM will be examined as predictors of differential treatment response in voucher VoucherPBCM versus tangible prize TangiblePBCM versions of PBCM Treatment-related change in neural and cognitive-behavioral correlates of FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups Veterans with CUD will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week treatment interval Pre- and post-treatment electroencephalography EEG and cognitive-behavioral assessments will be used to measure FMDM-related constructs working memory self-control future-oriented decision-making future reward representation and related neuromarkers These measures will be investigated as predictors of differential treatment response in VoucherPBCM versus TangiblePBCM as well as maintenance of gains during a post-treatment follow-up period Change in FMDM-related neural and cognitive measures over the course of treatment will also be evaluated for evidence of neuroadaptation eg changes in functional connectivity and enhancement of FMDM function through PBCM Taken together results of the current research project will represent a first step toward precision implementation of CM within the VA
This project aims to advance measurement-based implementation of CM by testing a novel neurocognitive model with immediate implications for the use of abstract versus concrete PBCM incentives within the VA Specifically the future-minded decision-making FMDM model posits that CM scaffolds future-oriented goal representation and self-control to support abstinence during in the moment use-related decision-making For individuals with greater FMDM impairment concrete readily-accessible incentives may be more effective than abstract voucher-based rewards which require future-oriented thinking and planning to acquire value To test this model neurocognitive substrates of FMDM will be examined as predictors of differential treatment response in voucher VoucherPBCM versus tangible prize TangiblePBCM versions of PBCM Treatment-related change in neural and cognitive-behavioral correlates of FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups Veterans with CUD will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week treatment interval Pre- and post-treatment electroencephalography EEG and cognitive-behavioral assessments will be used to measure FMDM-related constructs working memory self-control future-oriented decision-making future reward representation and related neuromarkers These measures will be investigated as predictors of differential treatment response in VoucherPBCM versus TangiblePBCM as well as maintenance of gains during a post-treatment follow-up period Change in FMDM-related neural and cognitive measures over the course of treatment will also be evaluated for evidence of neuroadaptation eg changes in functional connectivity and enhancement of FMDM function through PBCM Taken together results of the current research project will represent a first step toward precision implementation of CM within the VA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX001807-01A1 | OTHER_GRANT | VA CSRD | None |