Substance UseSBIRTNCT01683643
Screening, Brief Intervention, and Referral to Treatment for Offenders
A study testing SBIRT in people with Substance Use and HIV Infections, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Substance Use, HIV Infections
- What is being tested?
- SBIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 31 Mar 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The sample for the study will be drawn from an offender population who are within 2-3 weeks of their release from MCJ or CRDF in Los Angeles County. In addition, subjects must be:
- At least 18 years of age
- English or Spanish speaking
- Not subject to extended jail or prison sentence
- Able to provide informed consent to participate in the study
Who cannot join
- Study exclusion criteria:
- Inability to provide informed consent to study participation because of cognitive impairment.
- Inability to communicate in either English or Spanish
- Refusal to complete Locator form for follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Los Angeles, California, 90025
About this study
The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population.
Read the detailed description
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice that has been found to be effective in reducing alcohol and illicit drug use, mainly among persons recruited in medical centers, primary care offices, emergency rooms, and colleges and universities. But SBIRT has the potential to be applicable to other populations that have, or that are at risk for, substance use problems. In particular, offenders have high prevalence of drug and alcohol use at varying levels of severity and often do not receive adequate intervention, either because of limited availability of programs, low motivation, or lack of awareness of the consequences of their substance use.
The scientific aims of the study are:
- Assess the effectiveness of SBIRT with offenders in terms of participation in brief intervention (if so indicated) and enrollment in treatment (if so indicated).
- Assess the effectiveness of SBIRT with offenders in terms of drug use, criminal activity, and criminal justice involvement at 12 months following baseline.
- Determine whether there are differences in acceptability, participation, and outcomes between men and women.
- Determine the cost of providing the SBIRT intervention with this population.
The clinical aims of the study are:
- To complement the use of SBIRT within Los Angeles County's substance abuse treatment system.
- To expand prevention and treatment options for offenders with substance abuse problems.
To our knowledge, this would be the first rigorous test of SBIRT with an offender population.
We will recruit inmates at two Los Angeles County Sheriff jail facilities, one for men and one for women (25% of total sample), and randomly assign them to the treatment (SBIRT) group (N =400) or to the control (no intervention) group (N = 400). Baseline demographic data will be collected. Subjects in both groups will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles. Twelve months after study admission, all study participants will be contacted for a follow-up interview. We will obtain records-based data on arrests and jail incarceration over the follow-up period from the Sheriff's Department and the California Department of Justice. We will also collect subject participation in publicly-funded treatment from the Substance Abuse Prevention and Control Division of the Los Angeles County Department of Health.
- Conditions
- Substance Use, HIV Infections
- Being tested
- SBIRT, Control Group
- Medical subject headings
- Substance-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
Screening, brief intervention, and referral to treatment.
Control GroupBehavioural
Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT Group | Experimental | Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles. Receives: Behavioral: SBIRT |
| Control Group | Active comparator | Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in the use of drugs and alcohol
Measured: 12 months
Secondary outcomes (5)
Participation in treatment
Measured: 12 months
Rearrest and incarceration
Measured: 12 months
Quality of life
Measured: 12 months
A reduction in HIV risk behaviors
Measured: 12 months
The cost benefit of SBIRT for offenders
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startApr 2012
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Prendergast, University of California, Los Angeles
- Investigators
- Michael Prendergast, Ph.D, Principal investigator, UCLA Integrated Substance Abuse ProgramsJerry Cartier, M.A., Study director, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683643
- Sponsor's protocol ID
- R01DA031879
- Acronym
- SBIRT
- Status last verified
- May 2017
- First submitted
- 5 Sep 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prendergast ML, McCollister K, Warda U. A randomized study of the use of screening, brief intervention, and referral to treatment (SBIRT) for drug and alcohol use with jail inmates. J Subst Abuse Treat. 2017 Mar;74:54-64. doi: 10.1016/j.jsat.2016.12.011. Epub 2016 Dec 30.
PubMed 28132701Prendergast ML, Cartier JJ. Screening, brief intervention, and referral to treatment (SBIRT) for offenders: protocol for a pragmatic randomized trial. Addict Sci Clin Pract. 2013 Oct 23;8(1):16. doi: 10.1186/1940-0640-8-16.
PubMed 24499609
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Brief Intervention, and Referral to Treatment for Offenders
- ClinicalTrials.gov ID
- NCT01683643
- Acronym / sponsor ID
- SBIRT / R01DA031879
- Conditions
- Substance Use, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 12 Sep 2012 (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.
The purpose of the study is to determine whether SBIRT is an effective intervention with inmates and to estimate the costs of providing SBIRT to this population.
Detailed description
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice that has been found to be effective in reducing alcohol and illicit drug use, mainly among persons recruited in medical centers, primary care offices, emergency rooms, and colleges and universities. But SBIRT has the potential to be applicable to other populations that have, or that are at risk for, substance use problems. In particular, offenders have high prevalence of drug and alcohol use at varying levels of severity and often do not receive adequate intervention, either because of limited availability of programs, low motivation, or lack of awareness of the consequences of their substance use.
The scientific aims of the study are:
- Assess the effectiveness of SBIRT with offenders in terms of participation in brief intervention (if so indicated) and enrollment in treatment (if so indicated).
- Assess the effectiveness of SBIRT with offenders in terms of drug use, criminal activity, and criminal justice involvement at 12 months following baseline.
- Determine whether there are differences in acceptability, participation, and outcomes between men and women.
- Determine the cost of providing the SBIRT intervention with this population.
The clinical aims of the study are:
- To complement the use of SBIRT within Los Angeles County's substance abuse treatment system.
- To expand prevention and treatment options for offenders with substance abuse problems.
To our knowledge, this would be the first rigorous test of SBIRT with an offender population.
We will recruit inmates at two Los Angeles County Sheriff jail facilities, one for men and one for women (25% of total sample), and randomly assign them to the treatment (SBIRT) group (N =400) or to the control (no intervention) group (N = 400). Baseline demographic data will be collected. Subjects in both groups will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles. Twelve months after study admission, all study participants will be contacted for a follow-up interview. We will obtain records-based data on arrests and jail incarceration over the follow-up period from the Sheriff's Department and the California Department of Justice. We will also collect subject participation in publicly-funded treatment from the Substance Abuse Prevention and Control Division of the Los Angeles County Department of Health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT Group | Experimental | Behavioral: SBIRTBaseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles. |
| Control Group | Active comparator | Behavioral: Control GroupBaseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The sample for the study will be drawn from an offender population who are within 2-3 weeks of their release from MCJ or CRDF in Los Angeles County. In addition, subjects must be:
Key exclusion criteria (4 listed)
- Study exclusion criteria:
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 |
|---|---|---|
| SBIRTScreening, brief intervention, and referral to treatment. | Behavioural | SBIRT Group |
| Control GroupControl subjects will receive only their risk score and informational materials regarding the health risks of substance use. | Behavioural | Control Group |
Primary outcome
A reduction in the use of drugs and alcohol
Time frame: 12 months
5 secondary outcomes
Participation in treatment
Time frame: 12 months
Rearrest and incarceration
Time frame: 12 months
Quality of life
Time frame: 12 months
A reduction in HIV risk behaviors
Time frame: 12 months
The cost benefit of SBIRT for offenders
Time frame: 12 months
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 10 May 2017.
- Derived from this study: PubMed 28132701Prendergast ML, McCollister K, Warda U. A randomized study of the use of screening, brief intervention, and referral to treatment (SBIRT) for drug and alcohol use with jail inmates. J Subst Abuse Treat. 2017 Mar;74:54-64. doi: 10.1016/j.jsat.2016.12.011. Epub 2016 Dec 30.
- Derived from this study: PubMed 24499609Prendergast ML, Cartier JJ. Screening, brief intervention, and referral to treatment (SBIRT) for offenders: protocol for a pragmatic randomized trial. Addict Sci Clin Pract. 2013 Oct 23;8(1):16. doi: 10.1186/1940-0640-8-16.
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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.
Michael Prendergast, Ph.D principal investigator
UCLA Integrated Substance Abuse Programs
Jerry Cartier, M.A. study director
UCLA Integrated Substance Abuse Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT in people with Substance Use and HIV Infections, run by University of California, Los Angeles 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 5 inclusion and 4 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 10 May 2017. 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?
A reduction in the use of drugs and alcohol (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683643, which also lists 2 linked publications.
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 10 May 2017.