Abstinence-Linked Money Management Multisite

NCT01327586 | Completed Phase 2 DMC

• 2 other identifiers: 0904004971R01DA012952
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dual Diagnosis; Cocaine Abuse; Cocaine Dependence; Polysubstance Abuse

Keywords

disability; substance abuse; cocaine abuse; dual diagnosis; representative payee; HIV risk reduction

Outcome Measures

Primary Outcomes (1)

• Proportion of Urine toxicology tests without cocaine

  Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Secondary Outcomes (1)

• Unprotected sexual encounters

  Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (2)

ATM

EXPERIMENTAL

Advisor-Teller Money Manager

Behavioral: ATM

Individual Drug Counseling

ACTIVE COMPARATOR

Behavioral: Individual Drug Counseling

Interventions

ATM BEHAVIORAL

Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex

ATM

Individual Drug Counseling BEHAVIORAL

Standard individualized drug counseling, modified from that described by Woody and colleagues

Individual Drug Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has a conservator of person
• A history of violence towards clinical providers or predatory violence
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Greater Bridgeport Mental Health Center

Bridgeport, Connecticut, 06610, United States

Location

Capitol Region Mental Health Center

Hartford, Connecticut, 06112, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Marc I Rosen, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: April 1, 2011
• Study Start: December 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 30, 2020

Record last verified: 2014-07

Locations

US (2)