Cocaine Use DisorderWRAPNCT03799341
Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project
A study testing Prize-Based Contingency Management and Treatment As Usual Outpatient Substance Use Treatment in people with Cocaine Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Prize-Based Contingency Management and Treatment As Usual Outpatient Substance Use Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Electrophysiological Predictors and Indicators of Contingency Management Treatment Response
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.
Read the 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.
- Conditions
- Cocaine Use Disorder
- Being tested
- Prize-Based Contingency Management, Treatment As Usual Outpatient Substance Use Treatment
- Keywords
- Cocaine-Related Disorders, Contingency Management, Reward, Choice Behavior, Executive Function, Precision Medicine, Evidence-Based Practice, Prospective Thinking, Electroencephalography, Event-Related Potentials, Functional Connectivity
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prize-Based Contingency ManagementBehavioural
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.
Treatment As Usual Outpatient Substance Use TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Prize-Based Contingency Management; Behavioral: Treatment As Usual Outpatient Substance Use Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 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.
Measured: 12-Week Treatment Interval
Secondary outcomes (6)
% Contingency Management (CM) Sessions Attended Per Participant (CM Groups Only)
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.
Measured: 12-Week Treatment Interval
Total Non-CM Treatment Encounters Per Participant
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.
Measured: 12-Week Treatment Interval
% Self-Reported Cocaine-Abstinent Days During Treatment
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.
Measured: 12-Week Treatment Interval
% Self-Reported Drug- and Alcohol-Abstinent Days During Treatment
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.
Measured: 12-Week Treatment Interval
% Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)
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.
Measured: 6 Month Post-Treatment Interval
% Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)
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.
Measured: 6 Month Post-Treatment Interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start13 Nov 2019
- Primary completion31 Oct 2023
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 treatment adherent versus treatment non-adherent subgroups.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah E. Forster, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799341
- Sponsor's protocol ID
- NURA-002-18S
- Other IDs
- CX001807-01A1
- Acronym
- WRAP
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2019
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If possible, a de-identified, anonymized dataset will be created and shared. However, specific arrangements for sharing have not yet been made and options for data sharing (for example, the availability of data repositories for electroencephalographic data files), as well as VA policies regarding data sharing may change over the course of the study. A detailed plan for data sharing will be developed and approved upon completion of data collection.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Predictors and Indicators of Contingency Management Treatment Response
- ClinicalTrials.gov ID
- NCT03799341
- Acronym / sponsor ID
- WRAP / NURA-002-18S
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine-Related Disorders, Contingency Management, Reward, Choice Behavior, Executive Function, Precision Medicine, Evidence-Based Practice, Prospective Thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 treatment adherent versus treatment non-adherent subgroups.
| Arm | Type | Receives |
|---|---|---|
| Tangible Prize-Based Contingency Management (TangiblePBCM) | Experimental | Behavioral: Prize-Based Contingency Management, Behavioral: Treatment As Usual Outpatient Substance Use TreatmentFor 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. |
| Voucher Prize-Based Contingency Management (VoucherPBCM) | Experimental | Behavioral: Prize-Based Contingency Management, Behavioral: Treatment As Usual Outpatient Substance Use TreatmentFor 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prize-Based Contingency ManagementParticipants 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. | Behavioural | Tangible Prize-Based Contingency Management (TangiblePBCM), Voucher Prize-Based Contingency Management (VoucherPBCM) |
| Treatment As Usual Outpatient Substance Use TreatmentAll 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. | Behavioural | Tangible Prize-Based Contingency Management (TangiblePBCM), Voucher Prize-Based Contingency Management (VoucherPBCM) |
Primary outcome
% Cocaine-Negative Urine Specimens Per Participant
Time frame: 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)
Time frame: 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.
6 secondary outcomes
% Contingency Management (CM) Sessions Attended Per Participant (CM Groups Only)
Time frame: 12-Week Treatment Interval
Total Non-CM Treatment Encounters Per Participant
Time frame: 12-Week Treatment Interval
% Self-Reported Cocaine-Abstinent Days During Treatment
Time frame: 12-Week Treatment Interval
% Self-Reported Drug- and Alcohol-Abstinent Days During Treatment
Time frame: 12-Week Treatment Interval
% Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)
Time frame: 6 Month Post-Treatment Interval
% Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)
Time frame: 6 Month Post-Treatment Interval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. If possible, a de-identified, anonymized dataset will be created and shared. However, specific arrangements for sharing have not yet been made and options for data sharing (for example, the availability of data repositories for electroencephalographic data files), as well as VA policies regarding data sharing may change over the course of the study. A detailed plan for data sharing will be developed and approved upon completion of data collection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah E. Forster, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prize-Based Contingency Management and Treatment As Usual Outpatient Substance Use Treatment in people with Cocaine Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Cocaine-Negative Urine Specimens Per Participant (time frame: 12-Week Treatment Interval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.