Trial Outcomes & Findings for Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project (NCT NCT03799341)

NCT ID: NCT03799341

Last Updated: 2025-09-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: 12-Week Treatment Interval
• Results posted on: 2025-09-30

Participant Flow

Recruitment took place through the VA Pittsburgh Healthcare System and other local sites serving Veterans with Substance Use Disorders. Methods included mailings, provider referrals, public advertisements, event info tables, EHR screening, and announcements during therapy groups. Recruitment began in November 2019 but was paused due to COVID-19 from March 17, 2020, to January 15, 2021. It resumed thereafter and continued until enrollment ended on August 31, 2023.

Before randomization, participants completed a pre-screening interview. Those eligible were invited to enroll and proceed to full screening. Participants subsequently completed a baseline assessment visit that included biospecimen testing, interviews, questionnaires, cognitive-behavioral tasks, and an electroencephalography (EEG) session. Of the 122 unique Veterans prescreened, 63 met initial eligibility criteria and were enrolled in the study, with 45 subsequently proceeding to randomization.

Participant milestones

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
12-Week Treatment Interval STARTED	22	19	4
12-Week Treatment Interval COMPLETED	22	19	2
12-Week Treatment Interval NOT COMPLETED	0	0	2
Post-Tx Evaluation Session STARTED	22	19	2
Post-Tx Evaluation Session COMPLETED	17	13	2
Post-Tx Evaluation Session NOT COMPLETED	5	6	0
6-Month Post-Tx Follow-Up Period STARTED	22	19	0
6-Month Post-Tx Follow-Up Period COMPLETED	9	9	0
6-Month Post-Tx Follow-Up Period NOT COMPLETED	13	10	0

Reasons for withdrawal

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
12-Week Treatment Interval Withdrawal by Investigator	0	0	1
12-Week Treatment Interval Withdrawal by Subject	0	0	1
Post-Tx Evaluation Session Lost to Follow-up	4	4	0
Post-Tx Evaluation Session Declined or Unavailable	1	2	0
6-Month Post-Tx Follow-Up Period Lost to Follow-up	12	10	0
6-Month Post-Tx Follow-Up Period Withdrawal by Investigator	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=22 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=4 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.	Total n=45 Participants Total of all reporting groups
Age, Continuous	61.9 age in years STANDARD_DEVIATION 7.2 • n=5 Participants	57.5 age in years STANDARD_DEVIATION 7.9 • n=7 Participants	61.5 age in years STANDARD_DEVIATION 4.4 • n=5 Participants	60.0 age in years STANDARD_DEVIATION 7.5 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	4 Participants n=5 Participants	42 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	4 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	22 Participants n=5 Participants	19 Participants n=7 Participants	4 Participants n=5 Participants	45 Participants n=4 Participants
% Self-Reported Pre-Treatment Cocaine-Abstinent Days	84.0 % cocaine-abstinent days (past month) STANDARD_DEVIATION 18.0 • n=5 Participants	91.7 % cocaine-abstinent days (past month) STANDARD_DEVIATION 10.9 • n=7 Participants	83.7 % cocaine-abstinent days (past month) STANDARD_DEVIATION 12.7 • n=5 Participants	87.2 % cocaine-abstinent days (past month) STANDARD_DEVIATION 15.1 • n=4 Participants
% Self-Reported Pre-Treatment Drug- and Alcohol-Abstinent Days	70.8 % fully abstinent days (past month) STANDARD_DEVIATION 30.2 • n=5 Participants	71.2 % fully abstinent days (past month) STANDARD_DEVIATION 36.7 • n=7 Participants	60.7 % fully abstinent days (past month) STANDARD_DEVIATION 41.7 • n=5 Participants	70.1 % fully abstinent days (past month) STANDARD_DEVIATION 33.4 • n=4 Participants

PRIMARY outcome

Timeframe: 12-Week Treatment Interval

Population: Results for the TAU arm are summarized using descriptive statistics but are omitted from statistical comparisons due to insufficient data (n = 4, with 2 out of 4 withdrawn from the study).

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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=22 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=4 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Cocaine-Negative Urine Specimens Per Participant	42.2 % negative specimens per participant Standard Deviation 37.4	59.1 % negative specimens per participant Standard Deviation 34.5	51.0 % negative specimens per participant Standard Deviation 18.8

PRIMARY outcome

Timeframe: 12-Week Treatment Interval

Population: Results for the TAU arm are summarized using descriptive statistics but are omitted from statistical comparisons due to insufficient data (n = 4, with 2 out of 4 withdrawn from the study).

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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=22 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=4 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Longest Duration of Cocaine Abstinence (LDCA)	21.36 LDCA in days Standard Deviation 27.87	34.95 LDCA in days Standard Deviation 27.55	11.00 LDCA in days Standard Deviation 19.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=22 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Contingency Management (CM) Sessions Attended Per Participant (CM Groups Only)	51.7 % CM sessions attended per participant Standard Deviation 33.2	68.0 % CM sessions attended per participant Standard Deviation 31.2	—

SECONDARY outcome

Timeframe: 12-Week Treatment Interval

Population: Only participants with complete data for the 12-week treatment period were included in this measure. Accordingly, two participants who withdrew early were excluded from the TAU arm, and one participant was excluded from the TangiblePBCM arm due to missing data. Results for the TAU arm are summarized using descriptive statistics but are omitted from statistical comparisons due to insufficient data (n = 4, with 2 out of 4 withdrawn from the study).

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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=21 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=2 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Total Non-CM Treatment Encounters Per Participant	10.7 count of encounters per participant Standard Deviation 15.8	12.5 count of encounters per participant Standard Deviation 12.9	20.0 count of encounters per participant Standard Deviation 24.0

SECONDARY outcome

Timeframe: 12-Week Treatment Interval

Population: Two participants were excluded from each arm (TangiblePBCM, VoucherPBCM, TAU) due to missing self-reported substance use data (collected via timeline follow-back procedure) during the 12-week treatment interval. All participants included had complete self-report data for the full interval. Results for the TAU arm are summarized using descriptive statistics but are omitted from statistical comparisons due to insufficient data (n = 4, with 2 out of 4 withdrawn from the study).

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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=20 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=17 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=2 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Self-Reported Cocaine-Abstinent Days During Treatment	86.0 % cocaine abstinent days Standard Deviation 26.5	86.8 % cocaine abstinent days Standard Deviation 24.4	81.7 % cocaine abstinent days Standard Deviation 25.9

SECONDARY outcome

Timeframe: 12-Week Treatment Interval

Population: Two participants were excluded from each arm (TangiblePBCM, VoucherPBCM, TAU) due to missing self-reported substance use data (collected via timeline follow-back procedure) during the 12-week treatment interval. All participants included had complete self-report data for the full interval. Results for the TAU arm are summarized using descriptive statistics but are omitted from statistical comparisons due to insufficient data (n = 4, with 2 out of 4 withdrawn from the study).

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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=20 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=17 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) n=2 Participants A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Self-Reported Drug- and Alcohol-Abstinent Days During Treatment	72.6 % drug and alcohol abstinent days Standard Deviation 32.2	65.3 % drug and alcohol abstinent days Standard Deviation 39.6	56.4 % drug and alcohol abstinent days Standard Deviation 9.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=15 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)	86.1 % stimulant-abstinent days Standard Deviation 27.8	92.1 % stimulant-abstinent days Standard Deviation 11.5	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=19 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=15 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
% Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)	70.9 % drug and alcohol abstinent days Standard Deviation 37.6	72.7 % drug and alcohol abstinent days Standard Deviation 34.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-Treatment Follow-up

Population: To accommodate the smaller final sample relative to the original target, analyses of neural and cognitive-behavioral outcomes were combined across arms. A revised analytic plan, approved prior to analysis, examined longitudinal differences by treatment engagement (attendance) and abstinence across arms.

Theta synchronization between anterior cingulate cortex (Cz) and lateral prefrontal cortex (F3, F4, FC5, FC6) was measured to assess differences in functional connectivity between baseline and post-treatment (i.e., follow-up assessment conducted after the conclusion of the 12-week treatment interval) for high versus low conflict events. At each timepoint, phase locking value (PLV) was computed for 4 electrode pairs (Cz-F3, Cz-F4, Cz-FC5, Cz-FC6) across 3 stimulus conditions ranging from low to high conflict (Congruent, Intermediate-Incongruent, High-Incongruent) and for high-conflict error versus low-conflict correct responses in the Parametric Conflict Flankers task. A wavelet transformation isolated theta activity, and PLV was derived from normalized complex wavelet phases. PLV quantifies trial-to-trial phase synchrony (0-1), with 1 representing perfect synchrony. Descriptive data reported below represent the average PLV across the 4 electrode pairs.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=21 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Baseline Congruent	0.163 Phase Locking Value Standard Deviation 0.096	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Baseline Intermediate Incongruent	0.173 Phase Locking Value Standard Deviation 0.100	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Baseline High Incongruent	0.205 Phase Locking Value Standard Deviation 0.098	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Follow-Up Congruent	0.158 Phase Locking Value Standard Deviation 0.084	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Follow-Up Intermediate Incongruent	0.165 Phase Locking Value Standard Deviation 0.083	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Follow-Up High Incongruent	0.200 Phase Locking Value Standard Deviation 0.088	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Baseline Correct	0.169 Phase Locking Value Standard Deviation 0.099	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Baseline Error	0.273 Phase Locking Value Standard Deviation 0.146	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Follow-Up Correct	0.158 Phase Locking Value Standard Deviation 0.086	—	—
Difference in Control-related Theta Synchronization From Baseline to Post-Treatment Follow-Up Error	0.245 Phase Locking Value Standard Deviation 0.104	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-Treatment Follow-up

Population: To accommodate the smaller final sample relative to the original target, analyses of neural and cognitive-behavioral outcomes were combined across arms. A revised analytic plan, approved prior to analysis, examined longitudinal differences by treatment engagement (attendance) and abstinence across arms.

Difference in Brown-Peterson working memory scores between baseline and post-treatment (i.e., follow-up assessment conducted after the conclusion of the 12-week treatment interval). We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=27 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Difference in Executive Working Memory From Baseline to Post-Treatment Score at Baseline	24.37 total score Standard Deviation 7.82	—	—
Difference in Executive Working Memory From Baseline to Post-Treatment Score at Follow-up	24.78 total score Standard Deviation 7.90	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Post-Treatment Follow-up

Population: To accommodate the smaller final sample relative to the original target, analyses of neural and cognitive-behavioral outcomes were combined across arms. A revised analytic plan, approved prior to analysis, examined longitudinal differences by treatment engagement (attendance) and abstinence across arms.

Delay discounting was quantified using the hyperbolic discounting parameter (k), estimated separately for the Episodic Future Thinking (EFT) condition-with personally meaningful event tags anchoring delayed rewards-and the Standard condition without such tags. Values of k were natural log-transformed (ln(k)), with higher ln(k) indicating steeper discounting of delayed rewards, reflecting greater devaluation of future outcomes and a stronger preference for immediate gratification.

Outcome measures

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=28 Participants Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to TangiblePBCM, prizes are awarded in the form of tangible items, which are chosen from a physical "prize cabinet." Participants may redeem their draws for small, medium, large, or jumbo prizes, with medium prizes valued at approximately 5 small prizes. The cabinet is visible during sessions and restocked regularly, and the selection of prizes is guided by patient preference. All participants continue to receive their usual outpatient treatment and medications alongside PBCM.	Voucher Prize-Based Contingency Management (VoucherPBCM) Participants in this condition will receive Prize-Based Contingency Management (PBCM) as an adjunct to treatment as usual (TAU). During twice-weekly sessions, urine samples will be tested for cocaine, and each negative result earns the participant draws from a bowl of 500 paper slips, 250 of which award small, large, or jumbo prizes (the remaining slips deliver words of encouragement). Each consecutive negative adds an additional draw (up to 8), while a positive or missed test resets the draw count. For participants assigned to VoucherPBCM, prize draws resulting in small, large, or jumbo wins are rewarded with VA Canteen vouchers of corresponding value. These vouchers can be redeemed at Veterans Canteen Service vendors, including the hospital cafeteria and Patriot Store.	Treatment As Usual (TAU) A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Difference in Episodic Future Thinking Effect on Delay Discounting From Baseline to Post-Treatment EFT ln(k) Baseline	-3.62 ln(k) delay discounting parameter Standard Deviation 2.15	—	—
Difference in Episodic Future Thinking Effect on Delay Discounting From Baseline to Post-Treatment Standard ln(k) Baseline	-2.42 ln(k) delay discounting parameter Standard Deviation 3.28	—	—
Difference in Episodic Future Thinking Effect on Delay Discounting From Baseline to Post-Treatment EFT ln(k) Follow-up	-3.36 ln(k) delay discounting parameter Standard Deviation 2.47	—	—
Difference in Episodic Future Thinking Effect on Delay Discounting From Baseline to Post-Treatment Standard ln(k) Follow-up	-2.77 ln(k) delay discounting parameter Standard Deviation 3.30	—	—

Adverse Events

Tangible Prize-Based Contingency Management (TangiblePBCM)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Voucher Prize-Based Contingency Management (VoucherPBCM)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment As Usual (TAU)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tangible Prize-Based Contingency Management (TangiblePBCM) n=22 participants at risk 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.	Voucher Prize-Based Contingency Management (VoucherPBCM) n=19 participants at risk 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).	Treatment As Usual (TAU) n=4 participants at risk A treatment-as-usual (TAU) arm was originally included in the study design but was discontinued early in the trial due to evidence that its inclusion adversely affected participant accrual and retention among treatment-seeking individuals with cocaine use disorder. Participants randomized to TAU received standard care without the addition of prize-based contingency management (PBCM). Although they were still required to submit urine samples twice weekly for testing, they did not receive therapeutic incentives based on their urinalysis results.
Cardiac disorders hospitalization due to cardiac symptoms	4.5% 1/22 • Number of events 2 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	5.3% 1/19 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	25.0% 1/4 • Number of events 2 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
Psychiatric disorders hospitalization for psychiatric symptoms	13.6% 3/22 • Number of events 3 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	15.8% 3/19 • Number of events 5 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/4 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
Vascular disorders initial or prolonged hospitalization due to stroke	0.00% 0/22 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	5.3% 1/19 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	25.0% 1/4 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
General disorders hospitalization due to acute intoxication	0.00% 0/22 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	10.5% 2/19 • Number of events 2 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/4 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
Nervous system disorders hospitalization due to neurological symptoms	0.00% 0/22 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	5.3% 1/19 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/4 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
Infections and infestations hospitalization due to skin infection	0.00% 0/22 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	5.3% 1/19 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/4 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.
General disorders accidental overdose	4.5% 1/22 • Number of events 1 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/19 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.	0.00% 0/4 • from enrollment until 6 months post-treatment, up to 12 months SAEs are relatively common among individuals with chronic cocaine use disorder, often due to cocaine's adverse effects on cardiovascular and mental health. SAEs occurring during the pre-randomization period are reported under the arm to which participants were ultimately assigned, when applicable. Participants could continue to randomization if still determined eligible. One participant hospitalized during pre-randomization was withdrawn prior to randomization and is therefore not included.

Other adverse events

Adverse event data not reported

Additional Information

Sarah Forster, PhD

VA Pittsburgh Healthcare System

Phone: 412-209-9208

Email: sarah.forster2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place