Intervention to Reduce Injection Drug Use | NCT00786630

Studies
Intervention to Reduce Injection Drug Use

NCT00786630

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Dec 23, 2014Estimated

Enrollment

726Actual

Phase

Not Applicable

Conditions

Substance Abuse

Interventions

Strengths-based case management
Case management plus facilitated treatment alliance

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
2R01DA009832-11	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 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

Nov 2007

Primary Completion Date

Dec 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

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

Dec 19, 2014

Last Update Posted Date

Dec 23, 2014Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and to improve client overall functioning. The overall goal of this project is to compare strengths-based case-management (CM) to an enhanced version of CM that uses case managers to facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

726Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case Management	Experimental		Behavioral: Strengths-based case management
Facilitated Treatment Alliance	Experimental		Behavioral: Case management plus facilitated treatment alliance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strengths-based case management	Behavioral	Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment entry and retention		Baseline, 6 months after baseline, 12 months after baseline

Secondary Outcomes

Measure	Description	Time Frame
Drug injection and HIV/HCV risk behaviors		Baseline, 6 months after baseline, 12 months after baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

opiate injection at least 3 times a week during the last 6-months
18 years of age or older
no drug abuse treatment in the 30-days prior to the interview
not transient
no known reason (e.g. pending jail time) why they will not be available for follow-up interviews
not involved in Project Safe research activities in the previous 12 months
willing to meet with an Addiction Research and Treatment Services (methadone clinic) counselor
eligible to be treated at ARTS

Exclusion Criteria:

too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

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
Robert E. Booth, Ph.D.	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Project Safe		Denver	Colorado	80205	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019090	Case Management

Ancestor Terms

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided