Clinical trial NCT03799341: Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project
Official title: Electrophysiological Predictors and Indicators of Contingency Management Treatment Response
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: Cocaine-Related Disorders
Contingency Management
Reward
Choice Behavior
Executive Function
Precision Medicine
Evidence-Based Practice
Prospective Thinking
Electroencephalography
Event-Related Potentials
Functional Connectivity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients - both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups.
Primary purpose: TREATMENT

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 (e.g., 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 Veteran's 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 (i.e., 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 (e.g., 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.

Eligibility criteria: Inclusion Criteria:

* Military Veterans
* DSM-5 Criteria for Cocaine Use Disorder (Mild, Moderate, or Severe)
* Cocaine Use Within Past 60 Days
* Stated Goal of Cocaine Abstinence or Reduced Cocaine Use
* Normal or Corrected-to-Normal Vision
* Average or Corrected Hearing

Exclusion Criteria:

* History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Illness
* Severe or Unstable Medical or Psychiatric Condition
* Pregnant or Lactating Women
* Moderate-to-Severe Neurocognitive Impairment per Medical Record, SLUMS \< 21, or Mini MoCA \< 11
* In Ongoing Residential Treatment or Imminently Expected to Enter Residential Treatment During the Study Interval at Time of Screening

Primary outcomes:
measure: % Cocaine-Negative Urine Specimens
timeFrame: 12-Week Treatment Interval
measure: Longest Duration of Cocaine Abstinence
timeFrame: 12-Week Treatment Interval
Secondary outcomes:
measure: % Contingency Management (CM) Sessions Attended (CM Groups Only)
timeFrame: 12-Week Treatment Interval
measure: Total Non-CM Treatment Encounters
timeFrame: 12-Week Treatment Interval
measure: % Self-Reported Cocaine-Abstinent Days During Treatment
timeFrame: 12-Week Treatment Interval
measure: % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment
timeFrame: 12-Week Treatment Interval
measure: % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)
timeFrame: 6 Month Post-Treatment Interval
measure: % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)
timeFrame: 6 Month Post-Treatment Interval
Other outcomes:
measure: Pre- to Post-Treatment Change in Theta Synchronization
timeFrame: 12-Week Treatment Interval
measure: Pre- to Post-Treatment Change in Executive Working Memory
timeFrame: 12-Week Treatment Interval
measure: Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting)
timeFrame: 12-Week Treatment Interval
measure: Pre- to Post-Treatment Change Spontaneous Eyeblink Rate
timeFrame: 12-Week Treatment Interval
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Sarah E. Forster, PhD
role: PRINCIPAL_INVESTIGATOR
References: