Trial Outcomes & Findings for Cocaine Use Reduction and Health (NCT NCT03224546)

NCT ID: NCT03224546

Last Updated: 2024-08-01

Results Overview

Endothelin-1 levels will be measured. They will be recorded in pg/ml.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 127 participants
• Primary outcome timeframe: At baseline.
• Results posted on: 2024-08-01

Participant Flow

Participant milestones

Measure	Control Group This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Overall Study STARTED	42	41	44
Overall Study COMPLETED	26	19	29
Overall Study NOT COMPLETED	16	22	15

Reasons for withdrawal

Measure	Control Group This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Overall Study Lost to Follow-up	9	8	3
Overall Study Withdrawal by Subject	7	14	12

Baseline Characteristics

Cocaine Use Reduction and Health

Baseline characteristics by cohort

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	41 Participants n=7 Participants	44 Participants n=5 Participants	127 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	29 Participants n=5 Participants	84 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 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	32 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 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	42 participants n=5 Participants	41 participants n=7 Participants	44 participants n=5 Participants	127 participants n=4 Participants

PRIMARY outcome

Timeframe: At baseline.

Endothelin-1 levels will be measured. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Endothelin-1 Levels	2.15 pg/ml Standard Deviation .784	2.063 pg/ml Standard Deviation .699	1.956 pg/ml Standard Deviation .606

PRIMARY outcome

Timeframe: Week 6 of study participation

Population: Available participants to be measured.

Endothelin-1 levels will be measured. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=23 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=29 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Endothelin-1 Levels	1.886 pg/ml Standard Deviation .759	1.923 pg/ml Standard Deviation .478	1.939 pg/ml Standard Deviation .718

PRIMARY outcome

Timeframe: Week 12 of study participation

Population: Available participants to be measured.

Endothelin-1 levels will be measured. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Endothelin-1 Levels	2.093 pg/ml Standard Deviation 0.673	2.083 pg/ml Standard Deviation .772	2.086 pg/ml Standard Deviation .680

PRIMARY outcome

Timeframe: At baseline

Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	96.69 mm Hg Standard Deviation 15.77	97.22 mm Hg Standard Deviation 12.94	97.08 mm Hg Standard Deviation 11.93

PRIMARY outcome

Timeframe: Week 1 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=34 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=31 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=34 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	99.22 mm Hg Standard Deviation 16.45	99.66 mm Hg Standard Deviation 13.24	97.38 mm Hg Standard Deviation 13.18

PRIMARY outcome

Timeframe: Week 2 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=31 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=27 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=33 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	95.92 mm Hg Standard Deviation 15.85	99.78 mm Hg Standard Deviation 9.85	97.07 mm Hg Standard Deviation 14.03

PRIMARY outcome

Timeframe: Week 3 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=29 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=36 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	97 mm Hg Standard Deviation 13.57	100.5 mm Hg Standard Deviation 12.39	96.18 mm Hg Standard Deviation 12.06

PRIMARY outcome

Timeframe: Week 4 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=27 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=24 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=27 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	97.28 mm Hg Standard Deviation 15.08	102.02 mm Hg Standard Deviation 12.99	98.66 mm Hg Standard Deviation 12.41

PRIMARY outcome

Timeframe: Week 5 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=27 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=31 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	96.12 mm Hg Standard Deviation 14.78	99.72 mm Hg Standard Deviation 14.33	97.96 mm Hg Standard Deviation 13.18

PRIMARY outcome

Timeframe: Week 6 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=27 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=31 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	97.46 mm Hg Standard Deviation 13.51	100.93 mm Hg Standard Deviation 11.70	95.40 mm Hg Standard Deviation 13.23

PRIMARY outcome

Timeframe: Week 7 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=25 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=28 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	94.72 mm Hg Standard Deviation 14.88	100.13 mm Hg Standard Deviation 11.28	92.59 mm Hg Standard Deviation 12.29

PRIMARY outcome

Timeframe: Week 8 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=26 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	96.14 mm Hg Standard Deviation 14.84	100.05 mm Hg Standard Deviation 14.46	94.55 mm Hg Standard Deviation 12.38

PRIMARY outcome

Timeframe: Week 9 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=24 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=29 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	100.02 mm Hg Standard Deviation 16.59	100.19 mm Hg Standard Deviation 10.81	94.46 mm Hg Standard Deviation 12.21

PRIMARY outcome

Timeframe: Week 10 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=29 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	99.43 mm Hg Standard Deviation 17.18	102.68 mm Hg Standard Deviation 11.80	95.71 mm Hg Standard Deviation 13.60

PRIMARY outcome

Timeframe: Week 11 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=20 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=19 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	98.06 mm Hg Standard Deviation 15.53	101.31 mm Hg Standard Deviation 12.07	93.20 mm Hg Standard Deviation 11.05

PRIMARY outcome

Timeframe: Week 12 of participation

Population: Available participants to be measured.

Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

Outcome measures

Measure	Control Group n=23 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=18 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Mean Arterial Pressure	97.98 mm Hg Standard Deviation 14.21	102.10 mm Hg Standard Deviation 11.00	93.05 mm Hg Standard Deviation 11.89

SECONDARY outcome

Timeframe: At baseline.

Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Interleukin-10	.547 pg/ml Standard Deviation .750	.429 pg/ml Standard Deviation .424	.251 pg/ml Standard Deviation .106

SECONDARY outcome

Timeframe: Week 6 of study participation

Population: Available participants to be measured.

Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=23 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=29 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Interleukin-10	.587 pg/ml Standard Deviation 1.23	.329 pg/ml Standard Deviation .116	.257 pg/ml Standard Deviation .102

SECONDARY outcome

Timeframe: Week 12 of study participation

Population: Available participants to be measured.

Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Interleukin-10	.384 pg/ml Standard Deviation .663	.481 pg/ml Standard Deviation .514	.230 pg/ml Standard Deviation .907

SECONDARY outcome

Timeframe: At baseline

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	393.81 minutes Standard Deviation 135.91	379.27 minutes Standard Deviation 139.21	353.18 minutes Standard Deviation 118.31

SECONDARY outcome

Timeframe: Week 1 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=34 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=31 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	397.53 minutes Standard Deviation 135.60	413.45 minutes Standard Deviation 112.50	393.16 minutes Standard Deviation 121.13

SECONDARY outcome

Timeframe: Week 2 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=31 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=27 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=33 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	420.74 minutes Standard Deviation 149.37	447.76 minutes Standard Deviation 141.53	388.14 minutes Standard Deviation 136.68

SECONDARY outcome

Timeframe: Week 3 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=29 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=36 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	424.45 minutes Standard Deviation 145.55	414.5 minutes Standard Deviation 144.60	393.78 minutes Standard Deviation 110.19

SECONDARY outcome

Timeframe: Week 4 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=27 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=24 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=27 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	415.22 minutes Standard Deviation 149.02	390.10 minutes Standard Deviation 149.14	360.37 minutes Standard Deviation 132.39

SECONDARY outcome

Timeframe: Week 5 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=27 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=31 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	430.23 minutes Standard Deviation 119.61	426.49 minutes Standard Deviation 157.00	360 minutes Standard Deviation 144.31

SECONDARY outcome

Timeframe: Week 6 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=26 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=32 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	444.08 minutes Standard Deviation 108.42	394.46 minutes Standard Deviation 143.41	379.94 minutes Standard Deviation 120.34

SECONDARY outcome

Timeframe: Week 7 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=25 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=28 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	437.57 minutes Standard Deviation 99.48	421.11 minutes Standard Deviation 190.85	384.78 minutes Standard Deviation 118.26

SECONDARY outcome

Timeframe: Week 8 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=26 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	452.89 minutes Standard Deviation 117.21	395.74 minutes Standard Deviation 171.67	386.29 minutes Standard Deviation 130.64

SECONDARY outcome

Timeframe: Week 9 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=24 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=30 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	458.13 minutes Standard Deviation 123.29	426.67 minutes Standard Deviation 144.25	387.69 minutes Standard Deviation 135.79

SECONDARY outcome

Timeframe: Week 10 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=25 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=29 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	453.28 minutes Standard Deviation 95.52	405.44 minutes Standard Deviation 160.29	373.21 minutes Standard Deviation 148.41

SECONDARY outcome

Timeframe: Week 11 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=20 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=19 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	441.51 minutes Standard Deviation 96.25	389.79 minutes Standard Deviation 185.49	370.16 minutes Standard Deviation 144.97

SECONDARY outcome

Timeframe: Week 12 of participation

Population: Available participants to be measured.

Sleep time the night before in minutes

Outcome measures

Measure	Control Group n=23 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=18 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Total Sleep Time	435 minutes Standard Deviation 136.74	378.23 minutes Standard Deviation 150.62	387.05 minutes Standard Deviation 137.55

SECONDARY outcome

Timeframe: At baseline

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	4 score on a scale Interval 0.0 to 10.0	3 score on a scale Interval 0.0 to 7.0	5.5 score on a scale Interval 0.0 to 12.75

SECONDARY outcome

Timeframe: Week 1 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=30 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=22 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=33 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	2 score on a scale Interval 0.0 to 6.0	1.5 score on a scale Interval 0.0 to 6.5	4 score on a scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: Week 2 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=24 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=19 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=27 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.0	2 score on a scale Interval 0.0 to 5.5	3 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Week 3 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=26 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=20 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=25 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.75	1 score on a scale Interval 0.0 to 4.0	3 score on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Week 4 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=24 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 0.0 to 5.0	2.5 score on a scale Interval 0.0 to 6.75

SECONDARY outcome

Timeframe: Week 5 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=24 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=19 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=28 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 0.0 to 4.0	2 score on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Week 6 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=23 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=29 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	0 score on a scale Interval 0.0 to 2.5	1 score on a scale Interval 0.0 to 4.0	1 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Week 7 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=22 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=16 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.75	1.5 score on a scale Interval 0.0 to 4.75	0 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Week 8 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=18 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=21 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	2 score on a scale Interval 0.0 to 6.0	1 score on a scale Interval 0.0 to 2.75	1 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Week 9 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=15 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=22 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.0	0 score on a scale Interval 0.0 to 2.5	0.5 score on a scale Interval 0.0 to 2.25

SECONDARY outcome

Timeframe: Week 10 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=19 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=15 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=23 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 8.5	0 score on a scale Interval 0.0 to 1.5	1 score on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Week 11 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=19 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=18 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=20 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 4.0	0 score on a scale Interval 0.0 to 2.75	1 score on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Week 12 of Participation

Population: Available participants to be measured.

Score on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Hamilton Depression Scale Score	1 score on a scale Interval 0.0 to 3.0	0 score on a scale Interval 0.0 to 1.0	0 score on a scale Interval 0.0 to 3.75

SECONDARY outcome

Timeframe: At Baseline

Population: Available participants to be measured.

Number of criteria met on a Structured Clinical Interview as endorsed yes/no on a series of 11 questions on a scale. Range = 0-11. Higher scores indicate greater severity of Cocaine Use Disorder (e.g., more life problems due to cocaine use).

Outcome measures

Measure	Control Group n=42 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Criteria for Cocaine Use Disorder Diagnosis	8.4 number of criteria met Standard Deviation 1.9	7.2 number of criteria met Standard Deviation 2.0	8.6 number of criteria met Standard Deviation 1.8

SECONDARY outcome

Timeframe: Week 12 of Participation

Population: Available participants to be measured.

Number of criteria met on a Structured Clinical Interview as endorsed yes/no on a series of 11 questions on a scale. Range = 0-11. Higher scores indicate greater severity of Cocaine Use Disorder (e.g., more life problems due to cocaine use).

Outcome measures

Measure	Control Group n=21 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=26 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Criteria for Cocaine Use Disorder Diagnosis	6.2 number of criteria met Standard Deviation 3.2	4.8 number of criteria met Standard Deviation 2.7	6.5 number of criteria met Standard Deviation 2.2

SECONDARY outcome

Timeframe: At Baseline

Population: Available participants to be measured.

Measure of peripheral arterial tonomotry which assesses peripheral microvascular function through changes in amplitude of pulses in fingertips. Reactive hyperemia index (RHI) is "determined by calculating the ratio of hyperemic pressure (RHm) to baseline pressure (BLm) in the measurement and control arms (RHc and BLc respectively)" (Rosenberry and Nelson, 2020). This yields a natural log RHI ratio with higher scores indicating worse microvascular function. Being calculated as a natural log, there range is infinite.

Outcome measures

Measure	Control Group n=38 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=37 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=38 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Reactive Hyperemia Index	.61 ln(ratio) Standard Deviation .32	.63 ln(ratio) Standard Deviation .33	.51 ln(ratio) Standard Deviation .41

SECONDARY outcome

Timeframe: Week 12 of participation

Population: Available participants to be measured.

Measure of peripheral arterial tonomotry which assesses peripheral microvascular function through changes in amplitude of pulses in fingertips. Reactive hyperemia index (RHI) is "determined by calculating the ratio of hyperemic pressure (RHm) to baseline pressure (BLm) in the measurement and control arms (RHc and BLc respectively)" (Rosenberry and Nelson, 2020). This yields a natural log RHI ratio with higher scores indicating worse microvascular function. This yields a natural log RHI ratio with higher scores indicating worse microvascular function. Being calculated as a natural log, there range is infinite.

Outcome measures

Measure	Control Group n=20 Participants This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=17 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=23 Participants This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Reactive Hyperemia Index	.53 ln(ratio) Standard Deviation .37	.81 ln(ratio) Standard Deviation .40	.42 ln(ratio) Standard Deviation .54

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Low Value Alternative Reinforcer Group

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

High Value Alternative Reinforcer Group

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Group n=42 participants at risk This group will receive payment for providing urine samples throughout the trial.	Low Value Alternative Reinforcer Group n=41 participants at risk This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.	High Value Alternative Reinforcer Group n=44 participants at risk This group will receive payment for providing cocaine negative urine samples throughout the trial. Contingency Management: Subjects will receive payments for providing cocaine negative urine samples.
Cardiac disorders Abnormal ECG	19.0% 8/42 • Number of events 8 • 12 week clinical trial participation	19.5% 8/41 • Number of events 8 • 12 week clinical trial participation	22.7% 10/44 • Number of events 10 • 12 week clinical trial participation
Cardiac disorders Chest Pain	0.00% 0/42 • 12 week clinical trial participation	2.4% 1/41 • Number of events 1 • 12 week clinical trial participation	4.5% 2/44 • Number of events 2 • 12 week clinical trial participation
Renal and urinary disorders Elevated Creatine Kinase	4.8% 2/42 • Number of events 2 • 12 week clinical trial participation	4.9% 2/41 • Number of events 2 • 12 week clinical trial participation	2.3% 1/44 • Number of events 1 • 12 week clinical trial participation
Skin and subcutaneous tissue disorders Skin Irritation	4.8% 2/42 • Number of events 2 • 12 week clinical trial participation	7.3% 3/41 • Number of events 3 • 12 week clinical trial participation	4.5% 2/44 • Number of events 2 • 12 week clinical trial participation
Vascular disorders Difficult Blood Draw	7.1% 3/42 • Number of events 3 • 12 week clinical trial participation	2.4% 1/41 • Number of events 1 • 12 week clinical trial participation	6.8% 3/44 • Number of events 3 • 12 week clinical trial participation
Skin and subcutaneous tissue disorders Unusual/Unpleasant Skin Sensation	0.00% 0/42 • 12 week clinical trial participation	0.00% 0/41 • 12 week clinical trial participation	4.5% 2/44 • Number of events 2 • 12 week clinical trial participation
Psychiatric disorders Suicidal Ideation	4.8% 2/42 • Number of events 2 • 12 week clinical trial participation	0.00% 0/41 • 12 week clinical trial participation	0.00% 0/44 • 12 week clinical trial participation

Additional Information

William W. Stoops

University of Kentucky

Phone: 859-257-5383

Email: william.stoops@uky.edu

Results disclosure agreements

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