- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536900
Clinical Trial of Abstinence-Linked Money Management
Abstinence-Linked Money Management
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older.
- History of cocaine or alcohol abuse in the past 5 years
- Global Assessment of Functioning score below 65.
- Income of at least $450 per month.
- Able to provide informed consent, as evidenced by being able to answer questions about the study (described in Human Subjects).
- Enrolled at the New Haven Connecticut Mental Health Center (CMHC).
- 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:
- Evidence of physiological dependence on sedatives or alcohol requiring a detoxification.
- Has a conservator or a representative payee
- 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.
- Mentally Retarded, as evidenced by a DSM IV diagnosis of mental retardation or a clinical diagnosis of mental retardation.
- Individuals in recovery from pathological gambling.
- Individuals whose partner or spouse who co-manage their money is already enrolled in the study.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
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)
|
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weeks of abstinence
Time Frame: 36 weeks
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dollars spent on alcohol
Time Frame: 36 weeks
|
36 weeks
|
|
Dollars spent on drugs
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc I Rosen, M.D., Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0403026478
- R01DA012952 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
National Health Promotion Associates, Inc.UnknownSubstance Use | Substance Abuse | Prescription Drug Abuse (Not Dependent)
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Yale UniversityNational Institute on Drug Abuse (NIDA)CompletedChild Abuse | Parent-Child Relations | Parenting | Parents | Addiction | Child Neglect | Substance Abuse Drug Chronic | Child Neglect Emotional | Parent-Child Problem | Parent / Child Problem | Parenteral Drug AbuseUnited States
-
University of California, IrvineUS Department of Veterans AffairsWithdrawn
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse DisorderUnited States
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse DetectionUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Hammad MursaleenCompleted
Clinical Trials on Advisor-Teller Money Manager
-
US Department of Veterans AffairsCompleted