Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project

NCT03799341 | Completed Results DMC

• 2 other identifiers: NURA-002-18SCX001807-01A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• % Cocaine-Negative Urine Specimens Per Participant

  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.

  12-Week Treatment Interval

• Longest Duration of Cocaine Abstinence (LDCA)

  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.

  12-Week Treatment Interval

Secondary Outcomes (6)

• % Contingency Management (CM) Sessions Attended Per Participant (CM Groups Only)

  12-Week Treatment Interval

• Total Non-CM Treatment Encounters Per Participant

  12-Week Treatment Interval

• % Self-Reported Cocaine-Abstinent Days During Treatment

  12-Week Treatment Interval

• % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment

  12-Week Treatment Interval

• % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)

  6 Month Post-Treatment Interval

Other Outcomes (3)

• Difference in Control-related Theta Synchronization From Baseline to Post-Treatment

  Baseline and Post-Treatment Follow-up

• Difference in Executive Working Memory From Baseline to Post-Treatment

  Baseline and Post-Treatment Follow-up

• Difference in Episodic Future Thinking Effect on Delay Discounting From Baseline to Post-Treatment

  Baseline and Post-Treatment Follow-up

Study Arms (2)

Tangible Prize-Based Contingency Management (TangiblePBCM)

EXPERIMENTAL

For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols.

Behavioral: Prize-Based Contingency Management; Behavioral: Treatment As Usual Outpatient Substance Use Treatment

Voucher Prize-Based Contingency Management (VoucherPBCM)

EXPERIMENTAL

For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo).

Behavioral: Prize-Based Contingency Management; Behavioral: Treatment As Usual Outpatient Substance Use Treatment

Interventions

Prize-Based Contingency Management BEHAVIORAL

Participants assigned to Prize-based Contingency Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8 prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment.

Tangible Prize-Based Contingency Management (TangiblePBCM); Voucher Prize-Based Contingency Management (VoucherPBCM)

Treatment As Usual Outpatient Substance Use Treatment BEHAVIORAL

All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable.

Tangible Prize-Based Contingency Management (TangiblePBCM); Voucher Prize-Based Contingency Management (VoucherPBCM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Predictive analyses of differential treatment response in Tangible vs. Voucher PBCM, a key aim of the broader project, fall outside typical RCT reporting standards and will be reported separately. Recruitment was significantly impacted by the COVID-19 pandemic, resulting in a smaller sample than originally planned and reduced power. Outcomes related to delay discounting and theta phase synchronization may vary depending on specific analytic and preprocessing choices.

Results Point of Contact

• Title: Sarah Forster, PhD
• Organization: VA Pittsburgh Healthcare System

sarah.forster2@va.gov

412-209-9208

Study Officials

• Sarah E. Forster, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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 treatment adherent versus treatment non-adherent subgroups.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 10, 2019
• Study Start: November 13, 2019
• Primary Completion: October 31, 2023
• Study Completion: April 12, 2024
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)