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Clinical Trial of Abstinence-Linked Money Management

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ClinicalTrials.gov Identifier: NCT00536900
Recruitment Status : Completed
First Posted : September 28, 2007
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 26, 2007
First Posted Date  ICMJE September 28, 2007
Last Update Posted Date March 30, 2020
Study Start Date  ICMJE June 2004
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
weeks of abstinence [ Time Frame: 36 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
  • Dollars spent on alcohol [ Time Frame: 36 weeks ]
  • Dollars spent on drugs [ Time Frame: 36 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Abstinence-Linked Money Management
Official Title  ICMJE Abstinence-Linked Money Management
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Substance Abuse
Intervention  ICMJE
  • 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
  • Behavioral: FIT
    FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
Study Arms  ICMJE
  • Experimental: 1
    Advisor-Teller Money Manager
    Intervention: Behavioral: Advisor-Teller Money Manager
  • Active Comparator: 2
    FIT (finance instruction therapy)
    Intervention: Behavioral: FIT
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2007)
120
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00536900
Other Study ID Numbers  ICMJE 0403026478
R01DA012952 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Marc I Rosen, M.D. Yale University
PRS Account Yale University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP