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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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).
- Conditions
- Alcohol Dependence
- 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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2001
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Kenneth Silverman, PhD, Principal investigator, Johns Hopkins/Center for Learning and Health
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Workplace for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00183144
- Acronym / sponsor ID
- NIAAASIL12154
- Conditions
- Alcohol Dependence
- Keywords
- contingency management, reinforcement, employment, Therapeutic Workplace
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2001
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency management | Behavioural | – |
Primary outcome
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
4 secondary outcomes
percentage of urine samples negative for other drugs
percentage of participants employed each month
days employed per month
employment income per month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Silverman, PhD principal investigator
Johns Hopkins/Center for Learning and Health
1 site in 1 country: see every site and its status.
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.