NCT00183144

Brief Summary

The purpose of this study is to determine whether the Therapeutic Workplace is effective in increasing and maintaining long-term drug abstinence in homeless, alcohol dependent adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 19, 2010

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

May 18, 2010

Conditions

Alcohol Dependence

Keywords

contingency managementreinforcementemploymentTherapeutic Workplace

Outcome Measures

Primary Outcomes (4)

  • percentage of 30 day assessments that subjects reported alcohol abstinence

  • percentage of heavy drinking days

  • percentage of positive breath-alcohol tests

  • percent of patients meeting criteria for current alcohol dependence

Secondary Outcomes (4)

  • percentage of urine samples negative for other drugs

  • percentage of participants employed each month

  • days employed per month

  • employment income per month

Interventions

Contingency managementBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • meet DSM IV criteria for alcohol dependence
  • are homeless in that they lack a fixed nighttime residence
  • are unemployed
  • are at least 18 years old

You may not qualify if:

  • are currently physically dependent on opioids
  • are considered in imminent risk of suicide
  • have a psychiatric disorder that is likely to result in behaviors that could disrupt the workplace functioning or limit their ability to provide informed consent
  • are physically unable to perform typing or keypad entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kenneth Silverman, PhD

    Johns Hopkins/Center for Learning and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2001

Study Completion

April 1, 2006

Last Updated

May 19, 2010

Record last verified: 2007-10

Locations

US(1)