Substance UseEarly Phase 1NCT01661517
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting
A Early Phase 1 study testing Motivational interviewing and referral to treatment in people with Substance Use, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Substance Use
- What is being tested?
- Motivational interviewing and referral to treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,271 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2015
- Phase
- Early Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 and older Presentation to UAB Emergency Department
Who cannot join
- Younger than 19 Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham
Birmingham, Alabama, 35205
About this study
Official title: Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting (Screening and Brief Treatment for Substance Use Disorders in the Emergency Room Department)
This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.
- Conditions
- Substance Use
- Being tested
- Motivational interviewing and referral to treatment
- Keywords
- substance use treatment
- 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.
Motivational interviewing and referral to treatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Experimental | motivational interviewer Receives: Behavioral: Motivational interviewing and referral to treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
substance use
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionMay 2015
Why it stopped: incomplete data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661517
- Sponsor's protocol ID
- X110829003
- Status last verified
- Sep 2016
- First submitted
- 7 Aug 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting (Screening and Brief Treatment for Substance Use Disorders in the Emergency Room Department)
- ClinicalTrials.gov ID
- NCT01661517
- Acronym / sponsor ID
- X110829003
- Conditions
- Substance Use
- Keywords
- substance use treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: incomplete data
- Enrolment
- 5,271 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Aug 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.
This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Experimental | Behavioral: Motivational interviewing and referral to treatmentmotivational interviewer |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19 and older Presentation to UAB Emergency Department
Key exclusion criteria (1 listed)
- Younger than 19 Prisoners
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 |
|---|---|---|
| Motivational interviewing and referral to treatment | Behavioural | Lifestyle Counseling |
Primary outcome
substance use
Time frame: 2 years
Results and safety
The study was stopped early (reason given: incomplete data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Motivational interviewing and referral to treatment in people with Substance Use, run by University of Alabama at Birmingham 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 1 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: stopped early, as of the sponsor's last update on 18 Oct 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: incomplete data). Results are not available in the source record.
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?
substance use (time frame: 2 years). 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 18 Oct 2016.