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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00536900
Other study ID # 0403026478
Secondary ID R01DA012952
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2004
Est. completion date April 2009

Study information

Verified date July 2014
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
FIT
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets

Locations

Country Name City State
United States Connecticut Mental Health Center New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary weeks of abstinence 36 weeks
Secondary Dollars spent on alcohol 36 weeks
Secondary Dollars spent on drugs 36 weeks
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