Drug AddictionPhase 1NCT00607360
Integration of the Therapeutic Workplace in Drug Court
A Phase 1 study testing Therapeutic Workplace Intervention in people with Drug Addiction, run by National Institute on Drug Abuse (NIDA).
Trial summary
Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved offenders by providing 'judicially supervised' drug abuse treatment and probation for nonviolent offenders in lieu of criminal prosecution and incarceration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Therapeutic Workplace Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Jul 2007
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in Drug Court
- Report using any opiates and/or cocaine during 30 days prior to their arrest
- Unemployed
Who cannot join
- Individuals are excluded if they:
- Are at imminent risk of suicide
- Have a psychotic disorder that may limit their workplace functioning or their ability to provide informed consent
About this study
Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved offenders by providing 'judicially supervised' drug abuse treatment and probation for nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have shown that drug courts have modest effects on participation in drug abuse treatment, drug use, and employment. The Therapeutic Workplace intervention is an effective employment-based treatment that integrates abstinence reinforcement contingencies in a work setting, intended to treat individuals with histories of drug addiction and chronic unemployment. Under this intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients are required to provide drug-free urine samples to gain and maintain daily access in the workplace. In this way, patients can work and earn salary, but only as long as they remain drug abstinent. Patients using drugs and lacking job skills participate in an initial training phase to initiate abstinence and establish computer data entry skills. Once abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data entry business. Given that many drug court participants suffer from long histories of drug addiction and unemployment, the Therapeutic Workplace could be ideal for this population. This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in a Drug Court.
- Conditions
- Drug Addiction
- Being tested
- Therapeutic Workplace Intervention
- Keywords
- cocaine addiction, treatment, contingency management, employment intervention
- Medical subject headings
- Substance-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Workplace InterventionBehavioural
Therapeutic workplace intervention is intended for individuals with drug addiction and chronic unemployment. Participants are invited to participate in work and receive salary for participation and productivity contingent upon drug abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Standard Drug Court | No intervention | Participants received standard services from drug court |
| Drug Court plus Therapeutic Workplace | Experimental | Participants receive standard drug court services plus therapeutic workplace intervention Receives: Behavioral: Therapeutic Workplace Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startAug 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607360
- Sponsor's protocol ID
- 05-0865-F2L
- Other IDs
- 7R21DA017885-02
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of the Therapeutic Workplace in Drug Court
- ClinicalTrials.gov ID
- NCT00607360
- Acronym / sponsor ID
- 05-0865-F2L
- Conditions
- Drug Addiction
- Keywords
- cocaine addiction, treatment, contingency management, employment intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Feb 2008 (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.
Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved offenders by providing 'judicially supervised' drug abuse treatment and probation for nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have shown that drug courts have modest effects on participation in drug abuse treatment, drug use, and employment. The Therapeutic Workplace intervention is an effective employment-based treatment that integrates abstinence reinforcement contingencies in a work setting, intended to treat individuals with histories of drug addiction and chronic unemployment. Under this intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients are required to provide drug-free urine samples to gain and maintain daily access in the workplace. In this way, patients can work and earn salary, but only as long as they remain drug abstinent. Patients using drugs and lacking job skills participate in an initial training phase to initiate abstinence and establish computer data entry skills. Once abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data entry business. Given that many drug court participants suffer from long histories of drug addiction and unemployment, the Therapeutic Workplace could be ideal for this population. This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in a Drug Court.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Drug Court | No intervention | –Participants received standard services from drug court |
| Drug Court plus Therapeutic Workplace | Experimental | Behavioral: Therapeutic Workplace InterventionParticipants receive standard drug court services plus therapeutic workplace intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in Drug Court
- Report using any opiates and/or cocaine during 30 days prior to their arrest
- Unemployed
Key exclusion criteria (3 listed)
- Are at imminent risk of suicide
- Have a psychotic disorder that may limit their workplace functioning or their ability to provide informed consent
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 |
|---|---|---|
| Therapeutic Workplace InterventionTherapeutic workplace intervention is intended for individuals with drug addiction and chronic unemployment. Participants are invited to participate in work and receive salary for participation and productivity contingent upon drug abstinence. | Behavioural | Drug Court plus Therapeutic Workplace |
Primary outcome
Not reported in the source record.
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 10 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Therapeutic Workplace Intervention in people with Drug Addiction, run by National Institute on Drug Abuse (NIDA).
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 3 inclusion and 3 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 10 Jan 2017.