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Abstinence-Linked Money Management Multisite

Primary Purpose

Dual Diagnosis, Cocaine Abuse, Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATM
Individual Drug Counseling
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dual Diagnosis focused on measuring disability, substance abuse, cocaine abuse, dual diagnosis, representative payee, HIV risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in ambulatory psychiatric treatment at one of the participating clinics
  • Receives SSI or SSDI payments
  • Able to provide written informed consent
  • Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports

Exclusion Criteria:

  • Has a conservator of person
  • A history of violence towards clinical providers or predatory violence
  • Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
  • Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
  • Will not be able to complete the twelve months of the study because of anticipated incarceration or move
  • Had been enrolled in the ongoing study
  • Unable to speak and understand English

Sites / Locations

  • Greater Bridgeport Mental Health Center
  • Capitol Region Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ATM

Individual Drug Counseling

Arm Description

Advisor-Teller Money Manager

Outcomes

Primary Outcome Measures

Proportion of Urine toxicology tests without cocaine

Secondary Outcome Measures

Unprotected sexual encounters
ACASI-measured

Full Information

First Posted
February 2, 2011
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01327586
Brief Title
Abstinence-Linked Money Management Multisite
Official Title
Abstinence-Linked Money Management Multisite
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dual Diagnosis, Cocaine Abuse, Cocaine Dependence, Polysubstance Abuse
Keywords
disability, substance abuse, cocaine abuse, dual diagnosis, representative payee, HIV risk reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATM
Arm Type
Experimental
Arm Description
Advisor-Teller Money Manager
Arm Title
Individual Drug Counseling
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
ATM
Intervention Description
Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
Intervention Type
Behavioral
Intervention Name(s)
Individual Drug Counseling
Intervention Description
Standard individualized drug counseling, modified from that described by Woody and colleagues
Primary Outcome Measure Information:
Title
Proportion of Urine toxicology tests without cocaine
Time Frame
Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary Outcome Measure Information:
Title
Unprotected sexual encounters
Description
ACASI-measured
Time Frame
Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in ambulatory psychiatric treatment at one of the participating clinics Receives SSI or SSDI payments Able to provide written informed consent Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports Exclusion Criteria: Has a conservator of person A history of violence towards clinical providers or predatory violence Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal Will not be able to complete the twelve months of the study because of anticipated incarceration or move Had been enrolled in the ongoing study Unable to speak and understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc I Rosen, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Bridgeport Mental Health Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Capitol Region Mental Health Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.behaviorchange.yale.edu
Description
Related Info

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Abstinence-Linked Money Management Multisite

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