N/A
Completed N=56
The Therapeutic Workplace Initiation Study
Cocaine-Related Disorders · Opioid-Related Disorders · Heroin Dependence · Substance Abuse, Intravenous
Source: ClinicalTrials.gov NCT00249470 ↗
Enrolled (actual)
56
Serious AEs
10.7%
Results posted
Dec 2016
Primary outcomePrimary: Cocaine Abstinence — 29; 10 percentage of cocaine negative — p=.004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Abstinence |
29; 10 | .004 sig |
| SECONDARY Percent Opiate Negative |
55.4; 62.5 | =0.82 |
| SECONDARY HIV Risk Behaviors |
28.0; 16.1 | 0.04 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00249470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.