Intervention to Reduce Injection Drug Use
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ClinicalTrials.gov Identifier: NCT00786630 |
Recruitment Status
:
Completed
First Posted
: November 6, 2008
Last Update Posted
: December 23, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Substance Abuse | Behavioral: Strengths-based case management Behavioral: Case management plus facilitated treatment alliance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 726 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intervention to Reduce Injection Drug Use |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Case Management |
Behavioral: Strengths-based case management
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.
|
Experimental: Facilitated Treatment Alliance |
Behavioral: Case management plus facilitated treatment alliance
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. They will also receive a facilitated treatment alliance, which consists of meetings with methadone counselors to aid in treatment entry.
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- Treatment entry and retention [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ]
- Drug injection and HIV/HCV risk behaviors [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786630
United States, Colorado | |
Project Safe | |
Denver, Colorado, United States, 80205 |
Principal Investigator: | Robert E. Booth, Ph.D. | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT00786630 History of Changes |
Other Study ID Numbers: |
06-1131 2R01DA009832-11 ( U.S. NIH Grant/Contract ) |
First Posted: | November 6, 2008 Key Record Dates |
Last Update Posted: | December 23, 2014 |
Last Verified: | December 2014 |
Keywords provided by University of Colorado, Denver:
Drug treatment entry and retention Drug injection frequency HIV risk behaviors Hepatitis C risk behaviors |
Additional relevant MeSH terms:
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |