Substance AbusePhase 2NCT00536900
Clinical Trial of Abstinence-Linked Money Management
A Phase 2 study testing Advisor-Teller Money Manager and FIT in people with Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
This is a randomized controlled trial to test whether a money-management based intervention reduces substance abuse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Advisor-Teller Money Manager and FIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Abstinence-Linked Money Management
This is a randomized controlled trial to test whether a money-management based intervention reduces substance abuse.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Advisor-Teller Money Manager, FIT
- Keywords
- Substance abuse, Behavior therapy, representative payee, cocaine abuse, alcohol abuse, case management, dual diagnosis
- Medical subject headings
- Substance-Related Disorders, Cocaine-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advisor-Teller Money ManagerBehavioural
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
FITBehavioural
FIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Advisor-Teller Money Manager Receives: Behavioral: Advisor-Teller Money Manager |
| 2 | Active comparator | FIT (finance instruction therapy) Receives: Behavioral: FIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
weeks of abstinence
Measured: 36 weeks
Secondary outcomes (2)
Dollars spent on alcohol
Measured: 36 weeks
Dollars spent on drugs
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJun 2004
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marc I Rosen, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536900
- Sponsor's protocol ID
- 0403026478
- Other IDs
- R01DA012952
- Status last verified
- Jul 2014
- First submitted
- 26 Sep 2007
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20592006
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abstinence-Linked Money Management
- ClinicalTrials.gov ID
- NCT00536900
- Acronym / sponsor ID
- 0403026478
- Conditions
- Substance Abuse
- Keywords
- Substance abuse, Behavior therapy, representative payee, cocaine abuse, alcohol abuse, case management, dual diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Advisor-Teller Money ManagerAdvisor-Teller Money Manager |
| 2 | Active comparator | Behavioral: FITFIT (finance instruction therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advisor-Teller Money ManagerThe 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 | Behavioural | 1 |
| FITFIT (finance instruction therapy) involves review of a financial workbook and budgeting sheets | Behavioural | 2 |
Primary outcome
weeks of abstinence
Time frame: 36 weeks
2 secondary outcomes
Dollars spent on alcohol
Time frame: 36 weeks
Dollars spent on drugs
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 20592006Rosen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc I Rosen, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Advisor-Teller Money Manager and FIT in people with Substance Abuse, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weeks of abstinence (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.