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Cocaine Use Reduction and Health

Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03224546
Acronym
RCT (04)
Enrollment
127
Registered
2017-07-21
Start date
2017-09-15
Completion date
2024-01-15
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Use Disorder

Brief summary

Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.

Interventions

BEHAVIORALContingency Management

Subjects will receive payments for providing cocaine negative urine samples.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
William Stoops
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 or older * Self-report of recent cocaine use verified by a cocaine-positive urine sample * Meet moderate-severe Cocaine Use Disorder Criteria * Seeking treatment for their cocaine use * Able to commit to 12-week intervention, plus 24-week follow up

Exclusion criteria

* History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation * Current physical or psychiatric disease that would interfere with study participation * Poor veinous access, precluding blood draws

Design outcomes

Primary

MeasureTime frameDescription
Endothelin-1 LevelsAt baseline.Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial PressureAt baselineMean Arterial Pressure is recorded during participant visits and is recorded in mm Hg

Secondary

MeasureTime frameDescription
Hamilton Depression Scale ScoreAt baselineScore on the Hamilton Depression Inventory. Higher scores indicate greater depression symptoms. Minimum = 0, Maximum =56.
Total Sleep TimeAt baselineSleep time the night before in minutes
Reactive Hyperemia IndexAt BaselineMeasure 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.
Criteria for Cocaine Use Disorder DiagnosisAt BaselineNumber 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).
Interleukin-10At baseline.Interleukin-10 levels will be measured throughout subject participation. They will be recorded in pg/ml.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control Group
This group will receive payment for providing urine samples throughout the trial.
42
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.
41
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.
44
Total127

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up983
Overall StudyWithdrawal by Subject71412

Baseline characteristics

CharacteristicControl GroupLow Value Alternative Reinforcer GroupHigh Value Alternative Reinforcer GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
42 Participants41 Participants44 Participants127 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
32 Participants34 Participants34 Participants100 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants4 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants5 Participants5 Participants20 Participants
Region of Enrollment
United States
42 participants41 participants44 participants127 participants
Sex: Female, Male
Female
13 Participants15 Participants15 Participants43 Participants
Sex: Female, Male
Male
29 Participants26 Participants29 Participants84 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 410 / 44
other
Total, other adverse events
17 / 4215 / 4120 / 44
serious
Total, serious adverse events
0 / 420 / 410 / 44

Outcome results

Primary

Endothelin-1 Levels

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

Time frame: At baseline.

ArmMeasureValue (MEAN)Dispersion
Control GroupEndothelin-1 Levels2.15 pg/mlStandard Deviation 0.784
Low Value Alternative Reinforcer GroupEndothelin-1 Levels2.063 pg/mlStandard Deviation 0.699
High Value Alternative Reinforcer GroupEndothelin-1 Levels1.956 pg/mlStandard Deviation 0.606
Primary

Endothelin-1 Levels

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

Time frame: Week 12 of study participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupEndothelin-1 Levels2.093 pg/mlStandard Deviation 0.673
Low Value Alternative Reinforcer GroupEndothelin-1 Levels2.083 pg/mlStandard Deviation 0.772
High Value Alternative Reinforcer GroupEndothelin-1 Levels2.086 pg/mlStandard Deviation 0.68
Primary

Endothelin-1 Levels

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

Time frame: Week 6 of study participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupEndothelin-1 Levels1.886 pg/mlStandard Deviation 0.759
Low Value Alternative Reinforcer GroupEndothelin-1 Levels1.923 pg/mlStandard Deviation 0.478
High Value Alternative Reinforcer GroupEndothelin-1 Levels1.939 pg/mlStandard Deviation 0.718
Primary

Mean Arterial Pressure

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

Time frame: Week 6 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure97.46 mm HgStandard Deviation 13.51
Low Value Alternative Reinforcer GroupMean Arterial Pressure100.93 mm HgStandard Deviation 11.7
High Value Alternative Reinforcer GroupMean Arterial Pressure95.40 mm HgStandard Deviation 13.23
Primary

Mean Arterial Pressure

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

Time frame: Week 4 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure97.28 mm HgStandard Deviation 15.08
Low Value Alternative Reinforcer GroupMean Arterial Pressure102.02 mm HgStandard Deviation 12.99
High Value Alternative Reinforcer GroupMean Arterial Pressure98.66 mm HgStandard Deviation 12.41
Primary

Mean Arterial Pressure

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

Time frame: Week 7 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure94.72 mm HgStandard Deviation 14.88
Low Value Alternative Reinforcer GroupMean Arterial Pressure100.13 mm HgStandard Deviation 11.28
High Value Alternative Reinforcer GroupMean Arterial Pressure92.59 mm HgStandard Deviation 12.29
Primary

Mean Arterial Pressure

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

Time frame: Week 8 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure96.14 mm HgStandard Deviation 14.84
Low Value Alternative Reinforcer GroupMean Arterial Pressure100.05 mm HgStandard Deviation 14.46
High Value Alternative Reinforcer GroupMean Arterial Pressure94.55 mm HgStandard Deviation 12.38
Primary

Mean Arterial Pressure

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

Time frame: Week 9 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure100.02 mm HgStandard Deviation 16.59
Low Value Alternative Reinforcer GroupMean Arterial Pressure100.19 mm HgStandard Deviation 10.81
High Value Alternative Reinforcer GroupMean Arterial Pressure94.46 mm HgStandard Deviation 12.21
Primary

Mean Arterial Pressure

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

Time frame: Week 10 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure99.43 mm HgStandard Deviation 17.18
Low Value Alternative Reinforcer GroupMean Arterial Pressure102.68 mm HgStandard Deviation 11.8
High Value Alternative Reinforcer GroupMean Arterial Pressure95.71 mm HgStandard Deviation 13.6
Primary

Mean Arterial Pressure

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

Time frame: Week 11 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure98.06 mm HgStandard Deviation 15.53
Low Value Alternative Reinforcer GroupMean Arterial Pressure101.31 mm HgStandard Deviation 12.07
High Value Alternative Reinforcer GroupMean Arterial Pressure93.20 mm HgStandard Deviation 11.05
Primary

Mean Arterial Pressure

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

Time frame: Week 12 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure97.98 mm HgStandard Deviation 14.21
Low Value Alternative Reinforcer GroupMean Arterial Pressure102.10 mm HgStandard Deviation 11
High Value Alternative Reinforcer GroupMean Arterial Pressure93.05 mm HgStandard Deviation 11.89
Primary

Mean Arterial Pressure

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

Time frame: Week 2 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure95.92 mm HgStandard Deviation 15.85
Low Value Alternative Reinforcer GroupMean Arterial Pressure99.78 mm HgStandard Deviation 9.85
High Value Alternative Reinforcer GroupMean Arterial Pressure97.07 mm HgStandard Deviation 14.03
Primary

Mean Arterial Pressure

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

Time frame: Week 1 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure99.22 mm HgStandard Deviation 16.45
Low Value Alternative Reinforcer GroupMean Arterial Pressure99.66 mm HgStandard Deviation 13.24
High Value Alternative Reinforcer GroupMean Arterial Pressure97.38 mm HgStandard Deviation 13.18
Primary

Mean Arterial Pressure

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

Time frame: At baseline

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure96.69 mm HgStandard Deviation 15.77
Low Value Alternative Reinforcer GroupMean Arterial Pressure97.22 mm HgStandard Deviation 12.94
High Value Alternative Reinforcer GroupMean Arterial Pressure97.08 mm HgStandard Deviation 11.93
Primary

Mean Arterial Pressure

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

Time frame: Week 3 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure97 mm HgStandard Deviation 13.57
Low Value Alternative Reinforcer GroupMean Arterial Pressure100.5 mm HgStandard Deviation 12.39
High Value Alternative Reinforcer GroupMean Arterial Pressure96.18 mm HgStandard Deviation 12.06
Primary

Mean Arterial Pressure

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

Time frame: Week 5 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupMean Arterial Pressure96.12 mm HgStandard Deviation 14.78
Low Value Alternative Reinforcer GroupMean Arterial Pressure99.72 mm HgStandard Deviation 14.33
High Value Alternative Reinforcer GroupMean Arterial Pressure97.96 mm HgStandard Deviation 13.18
Secondary

Criteria for Cocaine Use Disorder Diagnosis

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).

Time frame: Week 12 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupCriteria for Cocaine Use Disorder Diagnosis6.2 number of criteria metStandard Deviation 3.2
Low Value Alternative Reinforcer GroupCriteria for Cocaine Use Disorder Diagnosis4.8 number of criteria metStandard Deviation 2.7
High Value Alternative Reinforcer GroupCriteria for Cocaine Use Disorder Diagnosis6.5 number of criteria metStandard Deviation 2.2
Secondary

Criteria for Cocaine Use Disorder Diagnosis

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).

Time frame: At Baseline

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupCriteria for Cocaine Use Disorder Diagnosis8.4 number of criteria metStandard Deviation 1.9
Low Value Alternative Reinforcer GroupCriteria for Cocaine Use Disorder Diagnosis7.2 number of criteria metStandard Deviation 2
High Value Alternative Reinforcer GroupCriteria for Cocaine Use Disorder Diagnosis8.6 number of criteria metStandard Deviation 1.8
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 10 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 5 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score2 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: At baseline

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score4 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score3 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score5.5 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 1 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score2 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1.5 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score4 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 2 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score2 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score3 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 3 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score3 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 4 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score2.5 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 6 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score0 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 7 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1.5 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 8 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score2 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 9 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score0.5 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 11 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score1 score on a scale
Secondary

Hamilton Depression Scale Score

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

Time frame: Week 12 of Participation

Population: Available participants to be measured.

ArmMeasureValue (MEDIAN)
Control GroupHamilton Depression Scale Score1 score on a scale
Low Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
High Value Alternative Reinforcer GroupHamilton Depression Scale Score0 score on a scale
Secondary

Interleukin-10

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

Time frame: Week 12 of study participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupInterleukin-10.384 pg/mlStandard Deviation 0.663
Low Value Alternative Reinforcer GroupInterleukin-10.481 pg/mlStandard Deviation 0.514
High Value Alternative Reinforcer GroupInterleukin-10.230 pg/mlStandard Deviation 0.907
Secondary

Interleukin-10

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

Time frame: At baseline.

ArmMeasureValue (MEAN)Dispersion
Control GroupInterleukin-10.547 pg/mlStandard Deviation 0.75
Low Value Alternative Reinforcer GroupInterleukin-10.429 pg/mlStandard Deviation 0.424
High Value Alternative Reinforcer GroupInterleukin-10.251 pg/mlStandard Deviation 0.106
Secondary

Interleukin-10

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

Time frame: Week 6 of study participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupInterleukin-10.587 pg/mlStandard Deviation 1.23
Low Value Alternative Reinforcer GroupInterleukin-10.329 pg/mlStandard Deviation 0.116
High Value Alternative Reinforcer GroupInterleukin-10.257 pg/mlStandard Deviation 0.102
Secondary

Reactive Hyperemia Index

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.

Time frame: Week 12 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupReactive Hyperemia Index.53 ln(ratio)Standard Deviation 0.37
Low Value Alternative Reinforcer GroupReactive Hyperemia Index.81 ln(ratio)Standard Deviation 0.4
High Value Alternative Reinforcer GroupReactive Hyperemia Index.42 ln(ratio)Standard Deviation 0.54
Secondary

Reactive Hyperemia Index

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.

Time frame: At Baseline

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupReactive Hyperemia Index.61 ln(ratio)Standard Deviation 0.32
Low Value Alternative Reinforcer GroupReactive Hyperemia Index.63 ln(ratio)Standard Deviation 0.33
High Value Alternative Reinforcer GroupReactive Hyperemia Index.51 ln(ratio)Standard Deviation 0.41
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 5 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time430.23 minutesStandard Deviation 119.61
Low Value Alternative Reinforcer GroupTotal Sleep Time426.49 minutesStandard Deviation 157
High Value Alternative Reinforcer GroupTotal Sleep Time360 minutesStandard Deviation 144.31
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 1 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time397.53 minutesStandard Deviation 135.6
Low Value Alternative Reinforcer GroupTotal Sleep Time413.45 minutesStandard Deviation 112.5
High Value Alternative Reinforcer GroupTotal Sleep Time393.16 minutesStandard Deviation 121.13
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 6 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time444.08 minutesStandard Deviation 108.42
Low Value Alternative Reinforcer GroupTotal Sleep Time394.46 minutesStandard Deviation 143.41
High Value Alternative Reinforcer GroupTotal Sleep Time379.94 minutesStandard Deviation 120.34
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 7 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time437.57 minutesStandard Deviation 99.48
Low Value Alternative Reinforcer GroupTotal Sleep Time421.11 minutesStandard Deviation 190.85
High Value Alternative Reinforcer GroupTotal Sleep Time384.78 minutesStandard Deviation 118.26
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 8 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time452.89 minutesStandard Deviation 117.21
Low Value Alternative Reinforcer GroupTotal Sleep Time395.74 minutesStandard Deviation 171.67
High Value Alternative Reinforcer GroupTotal Sleep Time386.29 minutesStandard Deviation 130.64
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 9 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time458.13 minutesStandard Deviation 123.29
Low Value Alternative Reinforcer GroupTotal Sleep Time426.67 minutesStandard Deviation 144.25
High Value Alternative Reinforcer GroupTotal Sleep Time387.69 minutesStandard Deviation 135.79
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 10 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time453.28 minutesStandard Deviation 95.52
Low Value Alternative Reinforcer GroupTotal Sleep Time405.44 minutesStandard Deviation 160.29
High Value Alternative Reinforcer GroupTotal Sleep Time373.21 minutesStandard Deviation 148.41
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 11 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time441.51 minutesStandard Deviation 96.25
Low Value Alternative Reinforcer GroupTotal Sleep Time389.79 minutesStandard Deviation 185.49
High Value Alternative Reinforcer GroupTotal Sleep Time370.16 minutesStandard Deviation 144.97
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 12 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time435 minutesStandard Deviation 136.74
Low Value Alternative Reinforcer GroupTotal Sleep Time378.23 minutesStandard Deviation 150.62
High Value Alternative Reinforcer GroupTotal Sleep Time387.05 minutesStandard Deviation 137.55
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 2 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time420.74 minutesStandard Deviation 149.37
Low Value Alternative Reinforcer GroupTotal Sleep Time447.76 minutesStandard Deviation 141.53
High Value Alternative Reinforcer GroupTotal Sleep Time388.14 minutesStandard Deviation 136.68
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 4 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time415.22 minutesStandard Deviation 149.02
Low Value Alternative Reinforcer GroupTotal Sleep Time390.10 minutesStandard Deviation 149.14
High Value Alternative Reinforcer GroupTotal Sleep Time360.37 minutesStandard Deviation 132.39
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: Week 3 of participation

Population: Available participants to be measured.

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time424.45 minutesStandard Deviation 145.55
Low Value Alternative Reinforcer GroupTotal Sleep Time414.5 minutesStandard Deviation 144.6
High Value Alternative Reinforcer GroupTotal Sleep Time393.78 minutesStandard Deviation 110.19
Secondary

Total Sleep Time

Sleep time the night before in minutes

Time frame: At baseline

ArmMeasureValue (MEAN)Dispersion
Control GroupTotal Sleep Time393.81 minutesStandard Deviation 135.91
Low Value Alternative Reinforcer GroupTotal Sleep Time379.27 minutesStandard Deviation 139.21
High Value Alternative Reinforcer GroupTotal Sleep Time353.18 minutesStandard Deviation 118.31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026