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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00249470 |
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Date of registration:
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03/11/2005 |
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Primary sponsor: |
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Public title:
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Employment-Based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction - 1
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Scientific title:
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The Therapeutic Workplace Initiation Study |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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117 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00249470 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Silverman, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Baseline inclusion criteria:
- are at least 18 years of age
- are enrolled in methadone maintenance treatment in Baltimore
- provide a cocaine-positive urine sample at time of initial screening
- self-report cocaine use through intravenous route
- have visible evidence of intravenous drug use (i.e., track marks).
Baseline exclusion criteria:
- report current suicidal ideation
- if the individual reports hallucinations
- have physical limitations (e.g., broken fingers) that prevent the subject from
typing.
- Applicants reporting hallucinations are excluded because this is a characteristic of
a psychiatric disorder that is likely to result in behaviors that could disrupt the
workplace or functioning or limit their ability to provide informed consent.
Main study inclusion criteria:
- have attended the workplace regularly during 4-week baseline periods
- are still in methadone maintenance treatment at the end of the 4-week baseline period
- have provided at least two urine samples that test positive for cocaine during the
baseline period
- Individuals who are excluded from the main study will be allowed to complete their
8-week training program in the Therapeutic Workplace. They may also be invited to
participate in other studies ongoing at the Center for Learning and Health where this
research takes place.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cocaine-Related Disorders
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Heroin Dependence
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Opioid-Related Disorders
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Substance Abuse, Intravenous
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Intervention(s)
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Behavioral: Contingency management
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Primary Outcome(s)
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Percentage of Monday, Wednesday and Friday urine samples that are negative for cocaine
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Percentage of urine samples at the 30-day assessments that are negative for cocaine
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Secondary Outcome(s)
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HIV risk behaviors
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Percentage of 30-day assessment urine samples negative for opiates
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Percentage of 30-day assessments that subjects report complete opiate abstinence
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Percentage of 30-day periods that the subjects report complete cocaine abstinence
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Percentage of Monday, Wednesday and Friday urine samples that are negative for opiates
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Secondary ID(s)
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NIDA-12564-1
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R01-12564-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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