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Clinical Trial of Abstinence-Linked Money Management

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), September 2007

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00536900
  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 II

Drug Information available for:   8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))-    Cocaine hydrochloride    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Abstinence-Linked Money Management

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • weeks of abstinence [ Time Frame: 36 weeks ]

Secondary Outcome Measures:
  • Dollars spent on alcohol [ Time Frame: 36 weeks ]
  • Dollars spent on drugs [ Time Frame: 36 weeks ]

Estimated Enrollment:   120
Study Start Date:   June 2004
Estimated Study Completion Date:   March 2008

Arms Assigned Interventions
1: Experimental
ATM
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
2: Active Comparator
FIT
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:

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

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

Contacts
Contact: Karen Ablondi, MPH     203-974-7294     Karen.Ablondi@yale.edu    

Locations
United States, Connecticut
Connecticut Mental Health Center     Recruiting
      New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Investigators
Principal Investigator:     Marc I Rosen, M.D.     Yale University    
  More Information


Study ID Numbers:   R01DA12952
First Received:   September 26, 2007
Last Updated:   September 27, 2007
ClinicalTrials.gov Identifier:   NCT00536900
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Substance abuse  
Behavior therapy  
representative payee  
cocaine abuse  
alcohol abuse
case management
dual diagnosis

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Cocaine
Ethanol

ClinicalTrials.gov processed this record on October 24, 2008




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