NCT02487745

Brief Summary

The purpose of this clinical trial is to evaluate the effectiveness and economic benefits of a Wage Supplement Model of arranging long-term exposure to employment-based abstinence reinforcement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

July 1, 2022

Enrollment Period

3.8 years

First QC Date

June 19, 2015

Results QC Date

June 24, 2022

Last Update Submit

July 19, 2022

Conditions

Keywords

CocaineMethadoneEmploymentOpioids

Outcome Measures

Primary Outcomes (2)

  • The Percentage of Opiate- and Cocaine-negative Urine Samples

    (# opiate- and cocaine-negative urine samples/divided by possible #) x 100

    1 year

  • The Percentage of Participants Who Are Employed

    (# participants employed /divided by total # of participants) x 100

    1 year

Secondary Outcomes (9)

  • The Percentage of Participants Who Report Injecting Drugs

    1 year

  • The Percentage of Participants Who Report Trading Unprotected Sex for Drugs or Money

    1 year

  • The Percentage of Participants Who Report Sharing Injection Equipment

    1 year

  • The Percentage of Participants With Household Incomes Below the Federal Poverty Level

    1 year

  • The Percentage of Opiate- and Cocaine-negative Urine Samples Post-intervention

    Year 2

  • +4 more secondary outcomes

Other Outcomes (1)

  • Cost-benefit of Treatment

    2 years

Study Arms (2)

IPS Only

ACTIVE COMPARATOR

IPS Only participants will receive the Individual Placement and Support (IPS) supported employment.

Behavioral: Individual Placement and Support (IPS) supported employment

IPS Plus Wage Supplement

EXPERIMENTAL

IPS Plus Abstinence-Contingent Wage Supplement participants will receive the Individual Placement and Support (IPS) supported employment intervention and abstinence-contingent wage supplements.

Behavioral: Abstinence-contingent wage supplementsBehavioral: Individual Placement and Support (IPS) supported employment

Interventions

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.

IPS Plus Wage Supplement

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 OnlyIPS Plus Wage Supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • report heroin use

You may not qualify if:

  • report current suicidal or homicidal ideation;
  • have a severe psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Holtyn AF, Toegel F, Subramaniam S, Jarvis BP, Leoutsakos JM, Fingerhood M, Silverman K. Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial. J Epidemiol Community Health. 2020 May;74(5):445-452. doi: 10.1136/jech-2020-213761. Epub 2020 Feb 21.

MeSH Terms

Conditions

Substance Abuse, Intravenous

Interventions

Palliative CareMyo-Inositol-1-Phosphate SynthaseEmployment, Supported

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesIntramolecular LyasesIsomerasesEnzymesEnzymes and CoenzymesEmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitation

Results Point of Contact

Title
Kenneth Silverman
Organization
Johns Hopkins University School of Medicine

Study Officials

  • Kenneth Silverman, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 1, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

August 11, 2022

Results First Posted

August 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The data will be published in a peer-reviewed journal.

Locations