Clinical Trial of Abstinence-Linked Money Management

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00536900
First received: September 26, 2007
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Substance Abuse
Behavioral: Advisor-Teller Money Manager
Behavioral: FIT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Abstinence-Linked Money Management

Further study details as provided by Yale University:

Primary Outcome Measures:
  • weeks of abstinence [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dollars spent on alcohol [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Dollars spent on drugs [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: June 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Advisor-Teller Money Manager
Behavioral: 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)
Behavioral: FIT
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536900

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc I Rosen, M.D. Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00536900     History of Changes
Other Study ID Numbers: R01DA12952
Study First Received: September 26, 2007
Last Updated: July 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Substance abuse
Behavior therapy
representative payee
cocaine abuse
alcohol abuse
case management
dual diagnosis

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014