Abstinence-Linked Money Management Multisite
This study is currently recruiting participants.
Verified March 2011 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01327586
First received: February 2, 2011
Last updated: March 31, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mentally Ill Chemical Abuse Cocaine Abuse Cocaine Dependence Polysubstance Abuse |
Behavioral: ATM Behavioral: Individual Drug Counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Abstinence-Linked Money Management Multisite |
Further study details as provided by Yale University:
Primary Outcome Measures:
- Proportion of Urine toxicology tests without cocaine [ Time Frame: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Unprotected sexual encounters [ Time Frame: Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]ACASI-measured
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ATM |
Behavioral: ATM
Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
|
| Active Comparator: Individual Drug Counseling |
Behavioral: Individual Drug Counseling
Standard individualized drug counseling, modified from that described by Woody and colleagues
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327586
Contacts
| Contact: Karen Ablondi, MPH | 2039747294 | karen.ablondi@yale.edu |
Locations
| United States, Connecticut | |
| Greater Bridgeport Mental Health Center | Recruiting |
| Bridgeport, Connecticut, United States, 06610 | |
| Contact: Karen Ablondi, MPH 203-974-7294 Karen.Ablondi@yale.edu | |
| Contact karen.ablondi@yale.edu | |
| Capitol Region Mental Health Center | Recruiting |
| Hartford, Connecticut, United States, 06112 | |
| Contact: Karen Ablondi, MPH 203-974-7294 Karen.Ablondi@Yale.edu | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Marc I Rosen, M.D. | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marc I. Rosen, M.D., Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01327586 History of Changes |
| Other Study ID Numbers: | R01DA12952 from VACHS account |
| Study First Received: | February 2, 2011 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Yale University:
|
disability substance abuse cocaine abuse |
dual diagnosis representative payee HIV risk reduction |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013