A Therapeutic Workplace for Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

A Therapeutic Workplace for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183144
• Other study ID #: NIAAASIL12154
• Secondary ID: R01AA012154NIH R
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 18, 2010
• Start date: November 2001
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Few populations are beset with the constellation of economic, social and health problems that afflict homeless individuals. At the heart of much of this misfortune are staggering rates of alcoholism and drug addiction. While it is not clear whether substance abuse is a cause, consequence, or simply a correlate of homelessness, there is no question that substance abuse is among the most common and most serious problems facing the homeless. Given their unique set of serious and chronic problems, the Institute of Medicine has identified the homeless as a group of people in need of specialized substance abuse interventions. Prior research has shown that the Therapeutic Workplace intervention is effective in the treatment of chronically unemployed heroin and cocaine dependent individuals. The intervention integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Under this intervention, patients are paid to perform data entry jobs in the Therapeutic Workplace. Those lacking needed skills are given intensive training in basic academic and job skills. To reinforce abstinence from alcohol and drugs, patients are required to provide an alcohol-free breath sample and drug-free urine sample to gain entrance to the workplace each day. In this way, patients can work and earn salary only when they abstain from alcohol and drugs. Patients are paid in vouchers instead of cash to reduce the chance they will use their earnings to purchase alcohol or drugs.

A randomized trial was conducted to evaluate the efficacy of this intervention in homeless, alcohol-dependent adults who completed an inpatient alcohol detoxification. After the detoxification, 124 participants were invited to attend the workplace for 6 months. They were randomly assigned to one of three groups that differed in the requirements for voucher reinforcement. One group received the full therapeutic workplace intervention in which vouchers were contingent on both abstinence and work (Abstinence and Work group). A second group was paid for work, but did not have to provide an alcohol-free breath sample or drug-free urine sample to gain access to the workplace; their vouchers were contingent on work only (Work-Only group). A third group was invited to attend the therapeutic workplace but received no vouchers for work performed or abstinence achieved during treatment (No Voucher group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Contingency management

Locations

Country	Name	City	State
United States	Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of 30 day assessments that subjects reported alcohol abstinence
Primary	percentage of heavy drinking days
Primary	percentage of positive breath-alcohol tests
Primary	percent of patients meeting criteria for current alcohol dependence
Secondary	percentage of urine samples negative for other drugs
Secondary	percentage of participants employed each month
Secondary	days employed per month
Secondary	employment income per month