Employment-Based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction - 1
Recruitment status was Active, not recruiting
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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 |
- 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
- 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 |
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| United States, Maryland | |
| The Center for Learning and Health | |
| Baltimore, Maryland, United States, 21224 | |
| 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 Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013