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Clinical Trial of Abstinence-Linked Money Management

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Advisor-Teller Money Manager
FIT
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Substance abuse, Behavior therapy, representative payee, cocaine abuse, alcohol abuse, case management, dual diagnosis

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18 or older.
  2. History of cocaine or alcohol abuse in the past 5 years
  3. Global Assessment of Functioning score below 65.
  4. Income of at least $450 per month.
  5. Able to provide informed consent, as evidenced by being able to answer questions about the study (described in Human Subjects).
  6. Enrolled at the New Haven Connecticut Mental Health Center (CMHC).
  7. Able to provide at least 2 names, addresses and telephone numbers of at least 2 individuals who are likely to have knowledge of their whereabouts throughout study follow-up.

Exclusion Criteria:

  1. Evidence of physiological dependence on sedatives or alcohol requiring a detoxification.
  2. Has a conservator or a representative payee
  3. Already receiving active money management (e.g. by case manager) in which the therapist/money manager makes more than one direct payment per month on behalf of the beneficiary.
  4. Mentally Retarded, as evidenced by a DSM IV diagnosis of mental retardation or a clinical diagnosis of mental retardation.
  5. Individuals in recovery from pathological gambling.
  6. Individuals whose partner or spouse who co-manage their money is already enrolled in the study.
  7. In the opinion of the Principal Investigator, the patient is unable to comply with the protocol procedures as evidenced by behavior or clinical information obtained during the enrollment and screening process.

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Advisor-Teller Money Manager

FIT (finance instruction therapy)

Outcomes

Primary Outcome Measures

weeks of abstinence

Secondary Outcome Measures

Dollars spent on alcohol
Dollars spent on drugs

Full Information

First Posted
September 26, 2007
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
NCT00536900
Brief Title
Clinical Trial of Abstinence-Linked Money Management
Official Title
Abstinence-Linked Money Management
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (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
This is a randomized controlled trial to test whether a money-management based intervention reduces substance abuse.
Detailed Description
While the Social Security Administration (SSA) no longer provides benefits for individuals disabled by drug abuse per se, approximately 50% of recipients have a concomitant substance abuse disorder. Supported by disability payments, this substance abuse impedes recovery/remission from the comorbid mental disorder. Money management is widely implemented in dual diagnosis treatment - in patients assigned payees to manage their funds and in patients receiving case management - but whether money management reduces substance abuse is unproven. If shown to be effective, money management-based therapy can be logically integrated into these existing arrangements. There is no specific substance abuse focus to standard payee and case management arrangements. We have developed a money management-based therapy called Advisor-Teller money manager (the bank-like acronym is ATM). ATM involves having a patient voluntarily allow a therapist/money manager to limit the patients' access to his/her funds, thus preventing unrestricted access to cash from cueing substance use. Patients meet with therapist/money managers at least weekly. Meetings begin with a review of the previous week's expenditures, including expenditures for drugs and alcohol, and an on-site urine toxicology test and breathalyzer. Patients then plan a budget that is incompatible with drug use by budgeting funds for direct payment of expenses (such as rent), abstinence-compatible activities and long-term goals. Budgeting and planning will develop patients' skills at managing their funds. Dispensing procedures build upon the principles of therapeutic contracting. Patients contract to receive their funds for specific expenditures and then review the next week whether the funds were spent as planned. We are conducting a Stage 2 randomized clinical trial in which 120 patients will be randomly assigned to 36-weeks of either ATM or Finance Instruction Therapy (FIT), a low intensity intervention in which patients are given basic financial instruction to determine the efficacy of ATM in reducing substance use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance abuse, Behavior therapy, representative payee, cocaine abuse, alcohol abuse, case management, dual diagnosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Advisor-Teller Money Manager
Arm Title
2
Arm Type
Active Comparator
Arm Description
FIT (finance instruction therapy)
Intervention Type
Behavioral
Intervention Name(s)
Advisor-Teller Money Manager
Intervention Description
The acronym for the functions of ATM are TTT-- Teller (storing patient funds), Training patients by making and reviewing monthly budgets, and Treatment-Linked Spending in which weekly behavioral contracts link disbursement to completion of abstinence-related activities
Intervention Type
Behavioral
Intervention Name(s)
FIT
Intervention Description
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
Primary Outcome Measure Information:
Title
weeks of abstinence
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Dollars spent on alcohol
Time Frame
36 weeks
Title
Dollars spent on drugs
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older. History of cocaine or alcohol abuse in the past 5 years Global Assessment of Functioning score below 65. Income of at least $450 per month. Able to provide informed consent, as evidenced by being able to answer questions about the study (described in Human Subjects). Enrolled at the New Haven Connecticut Mental Health Center (CMHC). Able to provide at least 2 names, addresses and telephone numbers of at least 2 individuals who are likely to have knowledge of their whereabouts throughout study follow-up. Exclusion Criteria: Evidence of physiological dependence on sedatives or alcohol requiring a detoxification. Has a conservator or a representative payee Already receiving active money management (e.g. by case manager) in which the therapist/money manager makes more than one direct payment per month on behalf of the beneficiary. Mentally Retarded, as evidenced by a DSM IV diagnosis of mental retardation or a clinical diagnosis of mental retardation. Individuals in recovery from pathological gambling. Individuals whose partner or spouse who co-manage their money is already enrolled in the study. In the opinion of the Principal Investigator, the patient is unable to comply with the protocol procedures as evidenced by behavior or clinical information obtained during the enrollment and screening process.
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
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20592006
Citation
Rosen MI, Rounsaville BJ, Ablondi K, Black AC, Rosenheck RA. Advisor-Teller Money Manager (ATM) therapy for substance use disorders. Psychiatr Serv. 2010 Jul;61(7):707-13. doi: 10.1176/ps.2010.61.7.707.
Results Reference
derived

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Clinical Trial of Abstinence-Linked Money Management

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