NCT00249470

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
11.1 years until next milestone

Results Posted

Study results publicly available

December 16, 2016

Completed
Last Updated

December 27, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 3, 2005

Results QC Date

September 2, 2016

Last Update Submit

December 1, 2017

Conditions

Cocaine-Related DisordersOpioid-Related DisordersHeroin DependenceSubstance Abuse, Intravenous

Keywords

HIVHIV risk behaviorsHeroinCocaineMethadoneOpioid DependenceCocaine AbuseContingency managementalcohol & drug usesexual risk behaviors

Outcome Measures

Primary Outcomes (1)

  • Cocaine Abstinence

    Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine

    6 months

Secondary Outcomes (2)

  • Percent Opiate Negative

    every month for 6 months

  • HIV Risk Behaviors

    every month for 6 months

Study Arms (2)

Abstinence & Work

EXPERIMENTAL

Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Behavioral: Abstinence & Work

Work Only

OTHER

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Behavioral: Work Only

Interventions

Abstinence & WorkBEHAVIORAL

Participants in the Abstinence \& Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.

Abstinence & Work
Work OnlyBEHAVIORAL

Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

Work Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Silverman K, Wong CJ, Needham M, Diemer KN, Knealing T, Crone-Todd D, Fingerhood M, Nuzzo P, Kolodner K. A randomized trial of employment-based reinforcement of cocaine abstinence in injection drug users. J Appl Behav Anal. 2007 Fall;40(3):387-410. doi: 10.1901/jaba.2007.40-387.

    PMID: 17970256RESULT

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related DisordersHeroin DependenceSubstance Abuse, IntravenousSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Results Point of Contact

Title
Dr. Kenneth Silverman
Organization
Johns Hopkins School of Medicine: Department of Psychiatry
ksilverm@jhmi.edu
410-550-2694

Study Officials

  • Kenneth Silverman, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

April 1, 2003

Primary Completion

May 1, 2004

Study Completion

October 1, 2004

Last Updated

December 27, 2017

Results First Posted

December 16, 2016

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)