Trial Outcomes & Findings for The Long-Term Treatment of Drug Addiction and Unemployment (NCT NCT02487745)
NCT ID: NCT02487745
Last Updated: 2022-08-11
Results Overview
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
1 year
Results posted on
2022-08-11
Participant Flow
Participants were enrolled in a 3-month abstinence initiation phase (Phase 1) prior to random assignment.
Participant milestones
| Measure |
IPS Only
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
44
|
|
Overall Study
COMPLETED
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Long-Term Treatment of Drug Addiction and Unemployment
Baseline characteristics by cohort
| Measure |
IPS Only
n=47 Participants
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
n=44 Participants
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=113 Participants
|
44 Participants
n=163 Participants
|
89 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
41 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=113 Participants
|
23 Participants
n=163 Participants
|
50 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=113 Participants
|
38 Participants
n=163 Participants
|
84 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=113 Participants
|
28 Participants
n=163 Participants
|
51 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=113 Participants
|
14 Participants
n=163 Participants
|
36 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=113 Participants
|
44 Participants
n=163 Participants
|
91 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat
(# opiate- and cocaine-negative urine samples/divided by possible #) x 100
Outcome measures
| Measure |
IPS Only
n=47 Participants
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
n=44 Participants
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
|---|---|---|
|
The Percentage of Opiate- and Cocaine-negative Urine Samples
|
44.9 percentage of urine samples
Interval 0.0 to 100.0
|
64.6 percentage of urine samples
Interval 0.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 year(# participants employed /divided by total # of participants) x 100
Outcome measures
| Measure |
IPS Only
n=47 Participants
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
n=44 Participants
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
|---|---|---|
|
The Percentage of Participants Who Are Employed
|
27.7 percentage of participants
|
59.1 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year(# participants reporting injecting drugs /divided by total # of participants) x 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year(# participants reporting trading unprotected sex for drugs or money/divided by total # of participants) x 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year(# participants reporting sharing injection equip/divided by total # of participants) x 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year(# participants with incomes below federal poverty level/divided by total # of participants) x 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 2This will be measured after the intervention ends
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 2This will be measured after the intervention ends
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 2This will be measured after the intervention ends
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 2This will be measured after the intervention ends
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 2This will be measured after the intervention ends
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsThe Cost-Benefit Analysis (CBA) will compare the monetized benefits relative to costs
Outcome measures
Outcome data not reported
Adverse Events
IPS Only
Serious events: 8 serious events
Other events: 11 other events
Deaths: 4 deaths
IPS Plus Wage Supplement
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
IPS Only
n=47 participants at risk
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
n=44 participants at risk
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
|---|---|---|
|
General disorders
Death
|
8.5%
4/47 • Number of events 4 • 1 year
|
11.4%
5/44 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
leg amputated
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Renal and urinary disorders
kidney failure
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Nervous system disorders
stroke
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory problem
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
Other adverse events
| Measure |
IPS Only
n=47 participants at risk
IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
IPS Plus Wage Supplement
n=44 participants at risk
IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.
Abstinence-contingent wage supplements: Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
Individual Placement and Support (IPS) supported employment: Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Psychiatric disorders
depression
|
4.3%
2/47 • Number of events 2 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
finger injury
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Gastrointestinal disorders
flu-like symptoms
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Cardiac disorders
hypertension
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/44 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
6.4%
3/47 • Number of events 3 • 1 year
|
0.00%
0/44 • 1 year
|
|
Psychiatric disorders
psychiatric treatment
|
2.1%
1/47 • Number of events 1 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
0.00%
0/47 • 1 year
|
4.5%
2/44 • Number of events 2 • 1 year
|
|
Eye disorders
bumped eye
|
0.00%
0/47 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Infections and infestations
respiratory infection
|
0.00%
0/47 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Nervous system disorders
seizure
|
0.00%
0/47 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/47 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
Additional Information
Kenneth Silverman
Johns Hopkins University School of Medicine
Phone: 4105502694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place