Behavior, AddictiveNCT00249457
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
A study testing Contingency management in people with Behavior, Addictive and Cocaine Abuse, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Behavior, Addictive, Cocaine Abuse, Cocaine Dependence
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1996to Jan 2006
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.
Who cannot join
- Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Learning and Health
Baltimore, Maryland, 21224
About this study
Official title: A Therapeutic Workplace for Drug Abusers
The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.
Read the detailed description
The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.
- Conditions
- Behavior, Addictive, Cocaine Abuse, Cocaine Dependence, Heroin Dependence, Opioid Dependence
- Being tested
- Contingency management
- Keywords
- Behavior Therapy, Cocaine Abuse, Cocaine Dependence, Contingency Management, Heroin Dependence, Methadone, Opioid Dependence
- Medical subject headings
- Behavior, Addictive, Cocaine-Related Disorders, Heroin Dependence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Workplace | Experimental | Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments. Receives: Behavioral: Contingency management |
| Usual Care Control Group | No intervention | No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of urine samples at the assessments that were negative for cocaine
(total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100
Measured: every 30 days throughout fourth year
Percentage of urine samples at the assessments that were negative for opiates
(total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100
Measured: every 30 days throughout fourth year
Percentage of urine samples at the assessments that were negative for cocaine and opiates
(total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100
Measured: every 30 days throughout fourth year
Secondary outcomes (4)
HIV risk behaviors
Measured: every 30 days throughout fourth year
Percentage of participants employed each month
Measured: every 30 days throughout fourth year
Number of days employed each month
Measured: every 30 days throughout fourth year
Percentage of participants to self-report abstinence at all time points
Measured: every 30 days throughout fourth year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 1996
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, AddictiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Silverman, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249457
- Sponsor's protocol ID
- NIDA-13107-2
- Status last verified
- Oct 2017
- First submitted
- 3 Nov 2005
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data for this study have been published in a peer-reviewed journal.
Publications
Aklin WM, Wong CJ, Hampton J, Svikis DS, Stitzer ML, Bigelow GE, Silverman K. A therapeutic workplace for the long-term treatment of drug addiction and unemployment: eight-year outcomes of a social business intervention. J Subst Abuse Treat. 2014 Nov-Dec;47(5):329-38. doi: 10.1016/j.jsat.2014.06.013. Epub 2014 Jul 12.
PubMed 25124257
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Workplace for Drug Abusers
- ClinicalTrials.gov ID
- NCT00249457
- Acronym / sponsor ID
- NIDA-13107-2
- Conditions
- Behavior, Addictive, Cocaine Abuse, Cocaine Dependence, Heroin Dependence, Opioid Dependence
- Keywords
- Behavior Therapy, Cocaine Abuse, Cocaine Dependence, Contingency Management, Heroin Dependence, Methadone, Opioid Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 1996
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Nov 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 long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.
Detailed description
The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Workplace | Experimental | Behavioral: Contingency managementContingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments. |
| Usual Care Control Group | No intervention | –No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.
Key exclusion criteria (1 listed)
- Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).
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 managementInvited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift. | Behavioural | Therapeutic Workplace |
Primary outcome
Percentage of urine samples at the assessments that were negative for cocaine
Time frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100
Percentage of urine samples at the assessments that were negative for opiates
Time frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100
Percentage of urine samples at the assessments that were negative for cocaine and opiates
Time frame: every 30 days throughout fourth year
(total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100
4 secondary outcomes
HIV risk behaviors
Time frame: every 30 days throughout fourth year
Percentage of participants employed each month
Time frame: every 30 days throughout fourth year
Number of days employed each month
Time frame: every 30 days throughout fourth year
Percentage of participants to self-report abstinence at all time points
Time frame: every 30 days throughout fourth year
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 30 Oct 2017.
- Results publication: PubMed 25124257Aklin WM, Wong CJ, Hampton J, Svikis DS, Stitzer ML, Bigelow GE, Silverman K. A therapeutic workplace for the long-term treatment of drug addiction and unemployment: eight-year outcomes of a social business intervention. J Subst Abuse Treat. 2014 Nov-Dec;47(5):329-38. doi: 10.1016/j.jsat.2014.06.013. Epub 2014 Jul 12.
- Individual participant dataSharing planned: No. The data for this study have been published in a peer-reviewed journal.
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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, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Behavior, Addictive and Cocaine Abuse, 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 1 inclusion and 1 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 30 Oct 2017. 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.
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 urine samples at the assessments that were negative for cocaine (time frame: every 30 days throughout fourth year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249457, which also lists 1 linked publication.
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 30 Oct 2017.