Trial Outcomes & Findings for The Therapeutic Workplace Initiation Study (NCT NCT00249470)
NCT ID: NCT00249470
Last Updated: 2017-12-27
Results Overview
Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
6 months
Results posted on
2017-12-27
Participant Flow
56 completed the induction period and were randomly assigned to the two study groups.
Participant milestones
| Measure |
Abstinence & Work
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Therapeutic Workplace Initiation Study
Baseline characteristics by cohort
| Measure |
Abstinence & Work
n=28 Participants
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
n=28 Participants
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of Monday, Wednesday, Friday urine samples that are negative for cocaine
Outcome measures
| Measure |
Abstinence & Work
n=28 Participants
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
n=28 Participants
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
|---|---|---|
|
Cocaine Abstinence
|
29 percentage of cocaine negative
Interval 0.0 to 99.0
|
10 percentage of cocaine negative
Interval 0.0 to 64.0
|
SECONDARY outcome
Timeframe: every month for 6 monthsPopulation: intent to treat
(total number of opiate-negative urine samples divided by the total number of urine samples provided)\*100
Outcome measures
| Measure |
Abstinence & Work
n=28 Participants
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
n=28 Participants
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
|---|---|---|
|
Percent Opiate Negative
|
55.4 percentage of opiate negative
Interval 0.0 to 100.0
|
62.5 percentage of opiate negative
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: every month for 6 monthsPopulation: The data represent the mean percentage of participants that reported no injection drug use or crack cocaine use. Missing assessments were considered positive (i.e., injection drug or crack cocaine use).
Report no injection drug use or crack cocaine use.
Outcome measures
| Measure |
Abstinence & Work
n=28 Participants
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
n=28 Participants
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
|---|---|---|
|
HIV Risk Behaviors
|
28.0 percentage of participants
Interval 0.0 to 78.0
|
16.1 percentage of participants
Interval 0.0 to 67.0
|
Adverse Events
Abstinence & Work
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Work Only
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abstinence & Work
n=28 participants at risk
Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Abstinence \& Work: Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
|
Work Only
n=28 participants at risk
Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.
|
|---|---|---|
|
Cardiac disorders
Death from heart attack
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Cardiac disorders
Hospitalization for congestive heart failure
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Gastrointestinal disorders
Hospitalization for abdominal pain
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
General disorders
Hospitalization for general medical treatment
|
3.6%
1/28 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Hospitalization for inpatient surgery
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Hospitalization for infection
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kenneth Silverman
Johns Hopkins School of Medicine: Department of Psychiatry
Phone: 410-550-2694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place