Abstinence-Linked Money Management Multisite

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01327586
First received: February 2, 2011
Last updated: March 31, 2011
Last verified: March 2011
  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 April 16, 2014