Substance AbuseNCT00786630
Intervention to Reduce Injection Drug Use
A study testing Strengths-based case management and Case management plus facilitated treatment alliance in people with Substance Abuse, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Strengths-based case management and Case management plus facilitated treatment alliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Substance Abuse
- Being tested
- Strengths-based case management, Case management plus facilitated treatment alliance
- Keywords
- Drug treatment entry and retention, Drug injection frequency, HIV risk behaviors, Hepatitis C risk behaviors
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengths-based case managementBehavioural
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.
Case management plus facilitated treatment allianceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case Management | Experimental | Not described Receives: Behavioral: Strengths-based case management |
| Facilitated Treatment Alliance | Experimental | Not described Receives: Behavioral: Case management plus facilitated treatment alliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment entry and retention
Measured: Baseline, 6 months after baseline, 12 months after baseline
Secondary outcomes (1)
Drug injection and HIV/HCV risk behaviors
Measured: Baseline, 6 months after baseline, 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert E. Booth, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786630
- Sponsor's protocol ID
- 06-1131
- Other IDs
- 2R01DA009832-11
- Status last verified
- Dec 2014
- First submitted
- 4 Nov 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Injection Drug Use
- ClinicalTrials.gov ID
- NCT00786630
- Acronym / sponsor ID
- 06-1131
- Conditions
- Substance Abuse
- Keywords
- Drug treatment entry and retention, Drug injection frequency, HIV risk behaviors, Hepatitis C risk behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management | Experimental | Behavioral: Strengths-based case management |
| Facilitated Treatment Alliance | Experimental | Behavioral: Case management plus facilitated treatment alliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengths-based case managementClients 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. | Behavioural | Case Management |
| Case management plus facilitated treatment allianceClients 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. | Behavioural | Facilitated Treatment Alliance |
Primary outcome
Treatment entry and retention
Time frame: Baseline, 6 months after baseline, 12 months after baseline
1 secondary outcome
Drug injection and HIV/HCV risk behaviors
Time frame: Baseline, 6 months after baseline, 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E. Booth, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengths-based case management and Case management plus facilitated treatment alliance in people with Substance Abuse, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment entry and retention (time frame: Baseline, 6 months after baseline, 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.