Clinical Trial of Abstinence-Linked Money Management

March 27, 2020 updated by: Yale University

Abstinence-Linked Money Management

This is a randomized controlled trial to test whether a money-management based intervention reduces substance abuse.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Advisor-Teller Money Manager
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
Active Comparator: 2
FIT (finance instruction therapy)
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weeks of abstinence
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Dollars spent on alcohol
Time Frame: 36 weeks
36 weeks
Dollars spent on drugs
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Marc I Rosen, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 0403026478
  • R01DA012952 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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