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
  Purpose

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.


Condition Intervention
Cocaine-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Behavioral: Contingency management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Therapeutic Workplace Initiation Study

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 117
Study Start Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249470

Locations
United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249470     History of Changes
Other Study ID Numbers: NIDA-12564-1, R01-12564-1
Study First Received: November 3, 2005
Last Updated: January 22, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV
HIV risk behaviors
Heroin
Cocaine
Methadone
Opioid Dependence
Cocaine Abuse
Contingency management
alcohol & drug use
sexual risk behaviors

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014