Abstinence-Linked Money Management Multisite | NCT01327586

Studies
Abstinence-Linked Money Management Multisite

NCT01327586

Sponsor

Yale University

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

108Actual

Phase

Phase 2

Conditions

Dual Diagnosis
Cocaine Abuse
Cocaine Dependence
Polysubstance Abuse

Interventions

ATM
Individual Drug Counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA012952	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 2, 2011

First Submission Date that Met QC Criteria

Mar 31, 2011

First Posted Date

Apr 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2020

Last Update Posted Date

Mar 30, 2020Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATM	Experimental	Advisor-Teller Money Manager	Behavioral: ATM
Individual Drug Counseling	Active Comparator		Behavioral: Individual Drug Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATM	Behavioral	Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex	ATM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Urine toxicology tests without cocaine		Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Secondary Outcomes

Measure	Description	Time Frame
Unprotected sexual encounters	ACASI-measured	Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc I Rosen, M.D.	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Greater Bridgeport Mental Health Center		Bridgeport	Connecticut	06610	United States
Capitol Region Mental Health Center

ID	Term
D019970	Cocaine-Related Disorders
D019966	Substance-Related Disorders

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders