Trial Outcomes & Findings for Long-term Behavior Change - 1 (NCT NCT00158197)
NCT ID: NCT00158197
Last Updated: 2015-08-25
Results Overview
Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
3x/week for 16 weeks
Results posted on
2015-08-25
Participant Flow
Recruitment and enrollment began in January 2005 and ended . Individuals were recruited from the community via radio and newspaper ads, flyers, and word of mouth.
The main reasons individuals were excluded from the trial prior to group assignment was not meeting inclusion criteria and discontinuing treatment prior to randomization.
Participant milestones
| Measure |
Intermittent Predictable Schedule
Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Continuous Schedule
Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Intermittent Unpredictable Schedule
Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Standard
Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
28
|
29
|
|
Overall Study
COMPLETED
|
32
|
30
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Behavior Change - 1
Baseline characteristics by cohort
| Measure |
Intermittent Predictable Schedule
n=32 Participants
Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Continuous Voucher Schedule
n=30 Participants
Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Intermittent Unpredictable Schedule
n=28 Participants
Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Standard
n=29 Participants
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
|
Total
n=119 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
119 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 10 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
32 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
28 participants
n=5 Participants
|
29 participants
n=4 Participants
|
119 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3x/week for 16 weeksPopulation: All individuals randomized were included in the analysis (i.e., intention to treat).
Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
Outcome measures
| Measure |
Intermittent Predictable Schedule
n=1536 Urine samples
Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Continuous Voucher Schedule
n=1440 Urine samples
Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Intermittent Unpredictable Schedule
n=1344 Urine samples
Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Standard
n=1392 Urine samples
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
|
|---|---|---|---|---|
|
Methamphetamine Use During Intervention
|
65.17 percentage of negative urine samples
|
60.35 percentage of negative urine samples
|
57.74 percentage of negative urine samples
|
42.81 percentage of negative urine samples
|
PRIMARY outcome
Timeframe: 16 WeeksDrug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual
Outcome measures
| Measure |
Intermittent Predictable Schedule
n=32 Participants
Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Continuous Voucher Schedule
n=30 Participants
Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Intermittent Unpredictable Schedule
n=28 Participants
Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Standard
n=29 Participants
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
|
|---|---|---|---|---|
|
Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence
|
22.42 days
Standard Deviation 15.36
|
22.7 days
Standard Deviation 17.60
|
20.32 days
Standard Deviation 18.64
|
11.10 days
Standard Deviation 12.58
|
PRIMARY outcome
Timeframe: 1x/month for 4 monthsDrug use measured by urine toxicology conducted by on site EMIT assay over time
Outcome measures
| Measure |
Intermittent Predictable Schedule
n=128 Urine samples
Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Continuous Voucher Schedule
n=120 Urine samples
Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Intermittent Unpredictable Schedule
n=112 Urine samples
Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Standard
n=116 Urine samples
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
|
|---|---|---|---|---|
|
Methamphetamine Use, Follow-Up
|
90.79 percentage of negative urine samples
|
88.89 percentage of negative urine samples
|
88.62 percentage of negative urine samples
|
87.30 percentage of negative urine samples
|
Adverse Events
Continuous Voucher Schedule
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Intermittent Predictable Schedule
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Intermittent Unpredictable Schedule
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Voucher Schedule
n=119 participants at risk
Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
Intermittent Predictable Schedule
n=119 participants at risk
Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
Intermittent Unpredictable Schedule
n=119 participants at risk
Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, \& F for 12 wks and complete measures 1x/wk.
|
Standard
n=119 participants at risk
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
slipped vertebral disk
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Cardiac disorders
chest pain
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Injury, poisoning and procedural complications
back and lung injury
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Pregnancy, puerperium and perinatal conditions
child birth
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
pneumonia
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Endocrine disorders
Diabetes Mellitus, Type II
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Endocrine disorders
High glucose levels
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Endocrine disorders
breathing difficulty
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Nervous system disorders
nerve pain
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
Other adverse events
| Measure |
Continuous Voucher Schedule
n=119 participants at risk
Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
Intermittent Predictable Schedule
n=119 participants at risk
Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
Intermittent Unpredictable Schedule
n=119 participants at risk
Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, \& F for 12 wks and complete measures 1x/wk.
|
Standard
n=119 participants at risk
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, \& F) for twelve weeks and will complete study-related measures one time per week.
|
|---|---|---|---|---|
|
Eye disorders
eye surgery
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
abscesses on legs
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
rash and blisters
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
fever
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
decayed teeth
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
pain and swelling
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Eye disorders
eye lesions
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Infections and infestations
tooth pain
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Injury, poisoning and procedural complications
leg injury
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
|
Injury, poisoning and procedural complications
broken thumb
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.84%
1/119 • Number of events 1 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
0.00%
0/119 • Adverse Event data were collected at each study and follow-up visit, for 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place