Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project
- Conditions
- Cocaine Use Disorder
- Registration Number
- NCT03799341
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method % Cocaine-Negative Urine Specimens Per Participant 12-Week Treatment Interval Percentage of cocaine-negative urine specimens during the 12-week treatment interval out of the total number possible, computed on a per-participant basis. The denominator was adjusted for participants for whom a full course of treatment could not be delivered due to suspension of face-to-face research activities during the COVID-19 pandemic. Denominators were similarly adjusted for 2 TAU participants who withdrew from the study during the 12-week treatment interval. Descriptive statistics represent the mean and standard deviation of the per-participant percentage of cocaine-negative urine specimens, computed across participants within each arm.
Longest Duration of Cocaine Abstinence (LDCA) 12-Week Treatment Interval Longest period of objectively-verified abstinence from cocaine during treatment. It is noted that two TAU participants withdrew during the 12-week treatment interval. For these participants, the LDCA was computed for the pre-withdrawal period only.
- Secondary Outcome Measures
Name Time Method % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only) 6 Month Post-Treatment Interval Percentage of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval. For participants without complete data for the full 6-month post-treatment interval, the percentage of self-reported stimulant-abstinent days was computed based on the total number of days for which self-report data were available.
% Contingency Management (CM) Sessions Attended Per Participant (CM Groups Only) 12-Week Treatment Interval Percentage of CM treatment sessions attended out of the total number possible, computed on a per-participant basis. The denominator was adjusted for participants for whom a full course of treatment could not be delivered due to suspension of face-to-face research activities during the COVID-19 pandemic. Descriptive statistics represent the mean and standard deviation of the per-participant percentage of CM sessions attended, computed across participants within each arm.
Total Non-CM Treatment Encounters Per Participant 12-Week Treatment Interval Number of non-CM, recovery-oriented treatment encounters during the 12-week treatment interval, computed on a per-participant basis. Encounters were documented in the electronic health record (VA encounters) and/or self-reported (non-VA encounters, including interactions with mutual support communities). Because this measure reflects the absolute number of non-CM treatment encounters per participant, only individuals with complete data for the 12-week period were included.
% Self-Reported Cocaine-Abstinent Days During Treatment 12-Week Treatment Interval Percentage of self-reported cocaine-abstinent days during the 12-week treatment interval, computed on a per-participant basis. Only participants with complete self-report data for the full treatment interval were included.
% Self-Reported Drug- and Alcohol-Abstinent Days During Treatment 12-Week Treatment Interval Percentage of self-reported drug and alcohol-abstinent days during the 12-week treatment interval, computed on a per-participant basis. Only participants with complete self-report data for the full treatment interval were included.
% Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only) 6 Month Post-Treatment Interval Percentage of self-reported stimulant-abstinent days during the 6 month post-treatment interval. For participants without complete data for the full 6-month post-treatment interval, the percentage of self-reported stimulant-abstinent days was computed based on the total number of days for which self-report data were available.
Trial Locations
- Locations (1)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA🇺🇸Pittsburgh, Pennsylvania, United States