Overview

This trial is active, not recruiting.

Conditions cocaine-related disorders, opioid-related disorders, heroin dependence, substance abuse, intravenous
Treatment contingency management
Sponsor National Institute on Drug Abuse (NIDA)
Collaborator Johns Hopkins University
Start date April 2003
Trial size 117 participants
Trial identifier NCT00249470, NIDA-12564-1, R01-12564-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Percentage of urine samples at the 30-day assessments that are negative for cocaine
time frame:
Percentage of Monday, Wednesday and Friday urine samples that are negative for cocaine
time frame:

Secondary Outcomes

Measure
HIV risk behaviors
time frame:
Percentage of 30-day periods that the subjects report complete cocaine abstinence
time frame:
Percentage of 30-day assessment urine samples negative for opiates
time frame:
Percentage of 30-day assessments that subjects report complete opiate abstinence
time frame:
Percentage of Monday, Wednesday and Friday urine samples that are negative for opiates
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Therapeutic Workplace Initiation Study
Principal investigator Kenneth Silverman, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).