Dual DiagnosisPhase 2NCT01327586
Abstinence-Linked Money Management Multisite
A Phase 2 study testing ATM and Individual Drug Counseling in people with Dual Diagnosis and Cocaine Abuse, run by Yale University at 2 sites in United States.
Trial summary
Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Diagnosis, Cocaine Abuse, Cocaine Dependence
- What is being tested?
- ATM and Individual Drug Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jan 2014
- 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
- Enrolled in ambulatory psychiatric treatment at one of the participating clinics
- Receives SSI or SSDI payments
- Able to provide written informed consent
- Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports
Who cannot join
- Has a conservator of person
- A history of violence towards clinical providers or predatory violence
- Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
- Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
- Will not be able to complete the twelve months of the study because of anticipated incarceration or move
- Had been enrolled in the ongoing study
- Unable to speak and understand English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greater Bridgeport Mental Health Center
Bridgeport, Connecticut, 06610
Capitol Region Mental Health Center
Hartford, Connecticut, 06112
About this study
Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.
- Conditions
- Dual Diagnosis, Cocaine Abuse, Cocaine Dependence, Polysubstance Abuse
- Being tested
- ATM, Individual Drug Counseling
- Keywords
- disability, substance abuse, cocaine abuse, dual diagnosis, representative payee, HIV risk reduction
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATMBehavioural
Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
Individual Drug CounselingBehavioural
Standard individualized drug counseling, modified from that described by Woody and colleagues
| Study group | Role | What they receive |
|---|---|---|
| ATM | Experimental | Advisor-Teller Money Manager Receives: Behavioral: ATM |
| Individual Drug Counseling | Active comparator | Not described Receives: Behavioral: Individual Drug Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Urine toxicology tests without cocaine
Measured: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes (1)
Unprotected sexual encounters
ACASI-measured
Measured: Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual DiagnosisStudies 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
- 108 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
- NCT01327586
- Sponsor's protocol ID
- 0904004971
- Other IDs
- R01DA012952
- Status last verified
- Jul 2014
- First submitted
- 2 Feb 2011
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 Multisite
- ClinicalTrials.gov ID
- NCT01327586
- Acronym / sponsor ID
- 0904004971
- Conditions
- Dual Diagnosis, Cocaine Abuse, Cocaine Dependence, Polysubstance Abuse
- Keywords
- disability, substance abuse, cocaine abuse, dual diagnosis, representative payee, HIV risk reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Apr 2011 (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.
Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATM | Experimental | Behavioral: ATMAdvisor-Teller Money Manager |
| Individual Drug Counseling | Active comparator | Behavioral: Individual Drug Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in ambulatory psychiatric treatment at one of the participating clinics
- Receives SSI or SSDI payments
- Able to provide written informed consent
- Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports
Key exclusion criteria (7 listed)
- Has a conservator of person
- A history of violence towards clinical providers or predatory violence
- Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
- Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
- Will not be able to complete the twelve months of the study because of anticipated incarceration or move
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 |
|---|---|---|
| ATMWeekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex | Behavioural | ATM |
| Individual Drug CounselingStandard individualized drug counseling, modified from that described by Woody and colleagues | Behavioural | Individual Drug Counseling |
Primary outcome
Proportion of Urine toxicology tests without cocaine
Time frame: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
1 secondary outcome
Unprotected sexual encounters
Time frame: Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATM and Individual Drug Counseling in people with Dual Diagnosis and Cocaine Abuse, run by Yale University at 2 sites 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 4 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 2 sites 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?
Proportion of Urine toxicology tests without cocaine (time frame: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.