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Alcohol DependencePhase 2NCT00183144

A Therapeutic Workplace for Alcohol Dependence

A Phase 2 study testing Contingency management in people with Alcohol Dependence, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Dependence
What is being tested?
Contingency management
How many people
156 participants
Where
1 siteUnited States
Study dates
Nov 2001to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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.

Read the detailed 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).

Being tested
Contingency management
Keywords
contingency management, reinforcement, employment, Therapeutic Workplace
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency managementBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of 30 day assessments that subjects reported alcohol abstinence

  2. percentage of heavy drinking days

  3. percentage of positive breath-alcohol tests

  4. percent of patients meeting criteria for current alcohol dependence

Secondary outcomes (4)
  1. percentage of urine samples negative for other drugs

  2. percentage of participants employed each month

  3. days employed per month

  4. employment income per month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startNov 2001
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183144
Sponsor's protocol ID
NIAAASIL12154
Other IDs
R01AA012154, NIH RO1 - AA12154
Status last verified
Oct 2007
First submitted
13 Sep 2005
Last updated
19 May 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Contingency management in people with Alcohol Dependence, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of 30 day assessments that subjects reported alcohol abstinence. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2010.

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