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Employment-Based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249470
First received: November 3, 2005
Last updated: January 22, 2008
Last verified: January 2008

November 3, 2005
January 22, 2008
April 2003
Not Provided
  • Percentage of urine samples at the 30-day assessments that are negative for cocaine
  • Percentage of Monday, Wednesday and Friday urine samples that are negative for cocaine
Same as current
Complete list of historical versions of study NCT00249470 on ClinicalTrials.gov Archive Site
  • HIV risk behaviors
  • Percentage of 30-day periods that the subjects report complete cocaine abstinence
  • Percentage of 30-day assessment urine samples negative for opiates
  • Percentage of 30-day assessments that subjects report complete opiate abstinence
  • Percentage of Monday, Wednesday and Friday urine samples that are negative for opiates
Same as current
Not Provided
Not Provided
 
Employment-Based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction - 1
The Therapeutic Workplace Initiation Study

The primary purpose of the study is to determine if the central feature of the Therapeutic Workplace, the abstinence reinforcement contingency, is critical to initiate cocaine abstinence in injection drug using methadone patients who use cocaine consistently during methadone treatment. All subjects initially will be invited to attend the Therapeutic Workplace for an initial period, but abstinence will not be required to work during that time. During this initial period, vouchers will be contingent only on workplace attendance and performance on the training programs. Subjects (n=70) who attend the workplace consistently during the first 4 weeks of treatment, but who continue to use cocaine will be randomly assigned to a Work Only or an Abstinence Plus Work group. Subjects in the Work Only group will continue to be able to work independent of their urinalysis results. However, subjects in the Abstinence Plus Work group will be required to provide urine samples that show evidence of recent cocaine abstinence. Subjects in both groups will be invited to stay in the workplace for 6 months. We expect the subjects in the Abstinence and Work group will achieve higher rates of abstinence than the subjects in the Work Only group. This result would show that the abstinence reinforcement contingency (i.e., the requirement to provide cocaine-free urine samples to work and earn vouchers) is important in the initiation of abstinence in the study population.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cocaine-Related Disorders
  • Opioid-Related Disorders
  • Heroin Dependence
  • Substance Abuse, Intravenous
Behavioral: Contingency management
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
117
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00249470
NIDA-12564-1, R01-12564-1
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
National Institute on Drug Abuse (NIDA)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP