Clinical trial NCT00536900: Clinical Trial of Abstinence-Linked Money Management
Official title: Abstinence-Linked Money Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Abuse
Keywords: Substance abuse
Behavior therapy
representative payee
cocaine abuse
alcohol abuse
case management
dual diagnosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: weeks of abstinence
timeFrame: 36 weeks
Secondary outcomes:
measure: Dollars spent on alcohol
timeFrame: 36 weeks
measure: Dollars spent on drugs
timeFrame: 36 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.