Trial Outcomes & Findings for A Therapeutic Workplace to Address Poverty and Substance Use (NCT NCT03519009)
NCT ID: NCT03519009
Last Updated: 2024-06-27
Results Overview
Percentage of participants abstinent per month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
1 year
Results posted on
2024-06-27
Participant Flow
Participants were recruited from treatment clinics and recovery houses serving adults with alcohol use disorder, online job boards, and through compensated referrals by participants. Participants were recruited from 2 January 2019 through 5 March 2020 and from 29 October 2020 through 12 May 2022. The pause in recruitment was due to regional and institutional restrictions related to the COVID-19 pandemic. Most of the study was conducted remotely because of the COVID-19 pandemic.
This was a two-group randomized clinical trial. All participants completed a 1-month Phase 1 Induction and Initiation period and were then randomly assigned to an intervention or control group. After random assignment, participants completed a 6-month Phase 2 Intervention period and completed study assessments every month.
Participant milestones
| Measure |
IPS Plus Abstinence-Contingent Wage Supplement
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
|
Usual Care Control
Counseling and referrals to employment and treatment programs.
|
Induction Period
During the first week, participants were introduced to the workplace contingencies: they could earn $5 per hour for up to 4 h per day for contacting research staff each day. Participants who contacted research staff 4 out of 5 days during the first week were invited to continue. During the next 3 weeks, participants were given a TAC monitoring device and could earn $8 per hour for up to 4 h per day each weekday. These devices had different requirements for use, which made it necessary for the procedures to be tailored to the device used. The SCRAM device requires that participants provide an alcohol-negative breath sample prior to use. Because participants had to be abstinent from alcohol to begin using SCRAM, participants fitted with SCRAM devices could maintain maximum pay if they continued abstaining from alcohol use. If alcohol use was detected, pay was reset to $1 per hour. After being reset, pay rates could be raised by $1 per hour (up to $8 per hour) for each day without alcohol use. The BACtrack Skyn device does not require that participants provide an alcohol-negative breath sample to begin using the device. So, incentives for alcohol abstinence were not provided during the Induction period for participants fitted with BACtrack Skyn. Instead, incentives were provided for wearing the device each day.
|
|---|---|---|---|
|
Period 1, Phase 1
STARTED
|
0
|
0
|
152
|
|
Period 1, Phase 1
COMPLETED
|
0
|
0
|
119
|
|
Period 1, Phase 1
NOT COMPLETED
|
0
|
0
|
33
|
|
Period 2, Phase 2
STARTED
|
62
|
57
|
0
|
|
Period 2, Phase 2
COMPLETED
|
62
|
57
|
0
|
|
Period 2, Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Therapeutic Workplace to Address Poverty and Substance Use
Baseline characteristics by cohort
| Measure |
IPS Plus Abstinence-Contingent Wage Supplement
n=62 Participants
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
|
Usual Care Control
n=57 Participants
Counseling and referrals to employment and treatment programs.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent to treat
Percentage of participants abstinent per month
Outcome measures
| Measure |
IPS Plus Abstinence-Contingent Wage Supplement
n=62 Participants
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
|
Usual Care Control
n=57 Participants
Counseling and referrals to employment and treatment programs.
|
|---|---|---|
|
Alcohol Abstinence
|
82.8 percentage of participants
|
60.2 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: intent-to-treat
Percentage of participants employed per month
Outcome measures
| Measure |
IPS Plus Abstinence-Contingent Wage Supplement
n=62 Participants
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
|
Usual Care Control
n=57 Participants
Counseling and referrals to employment and treatment programs.
|
|---|---|---|
|
Employment
|
51.3 percentage of participants
|
31.6 percentage of participants
|
Adverse Events
IPS Plus Abstinence-Contingent Wage Supplement
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPS Plus Abstinence-Contingent Wage Supplement
n=62 participants at risk
Abstinence-contingent wage supplements are provided for obtaining and maintaining competitive employment.
IPS Plus Abstinence-Contingent Wage Supplement: Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
|
Usual Care Control
n=57 participants at risk
Counseling and referrals to employment and treatment programs.
|
|---|---|---|
|
General disorders
Hospitalization
|
3.2%
2/62 • Number of events 2 • 1 year
|
5.3%
3/57 • Number of events 3 • 1 year
|
|
General disorders
Cancer
|
1.6%
1/62 • Number of events 1 • 1 year
|
0.00%
0/57 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.6%
1/62 • Number of events 1 • 1 year
|
0.00%
0/57 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place