Drug AbuseSBIRTNCT01683227
Screening, Brief Intervention, and Referral to Treatment for Drug Use
A study testing Screening/motivational drug intervention in people with Drug Abuse, run by San Diego State University at 2 sites in United States.
Trial summary
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Screening/motivational drug intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Aug 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or over
- speak English or Spanish
- competent to give consent and interact
- drug use risk higher than alcohol use risk
Who cannot join
- under 18
- non english or spanish speaker
- no telephone where one can be reached
- too injured/sick to participate
- alcohol use risk higher than drug use risk
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Scripps Mercy Emergency Department and Trauma Unit
San Diego, California, 92103
UCSD Emergency Department and Trauma Unit
San Diego, California, 92103
About this study
Official title: Screening and Brief Intervention for Latino and Non-Latino White Drug Users
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically.
This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.
- Conditions
- Drug Abuse
- Being tested
- Screening/motivational drug intervention, Motivational placebo intervention
- Keywords
- drug use; emergency department; brief intervention
- Medical subject headings
- Substance-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening/motivational drug interventionBehavioural
Also called SBIRT
Screening and brief motivational intervention delivered in the ER to reduce drug use
Motivational placebo interventionBehavioural
Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
| Study group | Role | What they receive |
|---|---|---|
| Screening/motivational drug intervention | Experimental | Screening and brief intervention counseling matched to patient's risk level delivered in the ER Receives: Behavioral: Screening/motivational drug intervention |
| Motivational placebo intervention | Placebo comparator | Screening and brief intervention for driving and traffic safety Receives: Behavioral: Motivational placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
past 30 day drug use abstinence
Based on the addiction severity index-Lite
Measured: 6 months post intervention
Secondary outcomes (1)
Frequency of drug use
Based on composite score from the Addiction Severity Index-Lite
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionAug 2012
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 Drug AbuseStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan I. Woodruff, San Diego State University
- Investigators
- Susan I Woodruff, PhD, Principal investigator, San Diego State University, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683227
- Sponsor's protocol ID
- 1RC1DA028031-01
- Acronym
- SBIRT
- Status last verified
- Apr 2016
- First submitted
- 7 Sep 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Woodruff SI, Clapp JD, Eisenberg K, McCabe C, Hohman M, Shillington AM, Sise CB, Castillo EM, Chan TC, Sise MJ, Gareri J. Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study. Addict Sci Clin Pract. 2014 May 22;9(1):8. doi: 10.1186/1940-0640-9-8.
PubMed 24886786Eisenberg K, Woodruff SI. Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients. Addict Sci Clin Pract. 2013 Apr 8;8(1):8. doi: 10.1186/1940-0640-8-8.
PubMed 23566363
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Intervention for Latino and Non-Latino White Drug Users
- ClinicalTrials.gov ID
- NCT01683227
- Acronym / sponsor ID
- SBIRT / 1RC1DA028031-01
- Conditions
- Drug Abuse
- Keywords
- drug use; emergency department; brief intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 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.
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically.
This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening/motivational drug intervention | Experimental | Behavioral: Screening/motivational drug interventionScreening and brief intervention counseling matched to patient's risk level delivered in the ER |
| Motivational placebo intervention | Placebo comparator | Behavioral: Motivational placebo interventionScreening and brief intervention for driving and traffic safety |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or over
- speak English or Spanish
- competent to give consent and interact
- drug use risk higher than alcohol use risk
Key exclusion criteria (5 listed)
- under 18
- non english or spanish speaker
- no telephone where one can be reached
- too injured/sick to participate
- alcohol use risk higher than drug use risk
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 |
|---|---|---|
| Screening/motivational drug interventionAlso: SBIRTScreening and brief motivational intervention delivered in the ER to reduce drug use | Behavioural | Screening/motivational drug intervention |
| Motivational placebo interventionScreening and brief motivational intervention delivered in the ER to reduce driving and traffic risk | Behavioural | Motivational placebo intervention |
Primary outcome
past 30 day drug use abstinence
Time frame: 6 months post intervention
Based on the addiction severity index-Lite
1 secondary outcome
Frequency of drug use
Time frame: 6 months post intervention
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 19 Apr 2016.
- Derived from this study: PubMed 24886786Woodruff SI, Clapp JD, Eisenberg K, McCabe C, Hohman M, Shillington AM, Sise CB, Castillo EM, Chan TC, Sise MJ, Gareri J. Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study. Addict Sci Clin Pract. 2014 May 22;9(1):8. doi: 10.1186/1940-0640-9-8.
- Derived from this study: PubMed 23566363Eisenberg K, Woodruff SI. Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients. Addict Sci Clin Pract. 2013 Apr 8;8(1):8. doi: 10.1186/1940-0640-8-8.
Related trials for Drug Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Clinician Practice Companion to Address Youth Substance Use
Substance Use, Substance-Related Disorders
Active, not recruiting
Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )
Well Being, Drug Addiction
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.
Susan I Woodruff, PhD principal investigator
San Diego State University, School of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening/motivational drug intervention in people with Drug Abuse, run by San Diego State University at 2 sites 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 4 inclusion and 5 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
past 30 day drug use abstinence (time frame: 6 months post intervention). 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 NCT01683227, 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 19 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.