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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01327586
Other study ID # 0904004971
Secondary ID R01DA012952
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2009
Est. completion date January 2014

Study information

Verified date July 2014
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
ATM
Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
Individual Drug Counseling
Standard individualized drug counseling, modified from that described by Woody and colleagues

Locations

Country Name City State
United States Greater Bridgeport Mental Health Center Bridgeport Connecticut
United States Capitol Region Mental Health Center Hartford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Urine toxicology tests without cocaine Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary Unprotected sexual encounters ACASI-measured Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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