Drug AbusePhase 3NCT01048359
Multidisciplinary Approach to Reduce Injury and Substance Abuse
A Phase 3 study testing Brief advice, Brief Intervention plus Booster and Brief Intervention in people with Drug Abuse, run by University of Texas at Austin at 1 site in United States.
Trial summary
The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Brief advice, Brief Intervention plus Booster and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2015
- Phase
- Phase 3
- 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
- Study participants must be 18 years or older
- Speak English or Spanish
- Been admitted to the level 1 Trauma Department
- Test positive for illegal drugs or admit to illegal drug use
Who cannot join
- Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites
- Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15
- Patients who do not pass the Mini-Mental Status Exam are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center Brackenridge
Austin, Texas, 78701
About this study
The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who abuse drugs and present to a trauma department for treatment of an injury.
Read the detailed description
Multidisciplinary Approach to Reduce Injury and Substance Abuse is a randomized clinical trial evaluating the effectiveness of brief advice (BA), brief motivational intervention with feedback (BMI), and brief motivational intervention with feedback and booster (BMI+B) in injured patients with drug problems.
The setting is a level 1 Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive toxicology screen or self reported drug use in the past 90 days. The primary outcome of interest will be patients' subsequent drug use. Other outcomes of interest include: HIV-related risk behaviors, improved health outcomes (including injury reduction), increased employment, decreased engagement in illegal behavior, increased substance abuse treatment utilization, and enhanced quality of life at three, six, and twelve month follow-ups.
This study will also examine the potential moderating and mediating effects of patient readiness to change, use of experiential and behavioral processes of change and decisional balance considerations. In addition, this project will examine implementation factors at the organizational level and the cost effectiveness of BA, BMI, and BMI+B.
Study participants and their related identifying information will be collected during the time they are admitted to the recruitment hospital trauma department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the recruitment hospital trauma department, and test positive for illegal drugs or admit to illegal drug use when verbally screened. Additional information will be collected from participants in the in-person assessment interviews at three, six, and 12 month follow-up periods.
- Conditions
- Drug Abuse
- Being tested
- Brief advice, Brief Intervention plus Booster, Brief Intervention
- Keywords
- Drug abuse, injury, trauma, screening, brief intervention.
- Medical subject headings
- Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief adviceBehavioural
The American College of Surgeons (ACS) recently mandated standards of care for all level I trauma centers and currently defined standards of care at the collaborating institution requires that assessment and referral are included in treatment as usual. Therefore, our treatment as usual, or BA, consists of an initial interview conducted by study staff, a recommendation to abstain from drug use, provision of educational material supporting that recommendation, referral to hospital or community treatment resources most likely to be beneficial to the patient and information about relevant community health care agencies.
Brief Intervention plus BoosterBehavioural
A brief drug use intervention based on motivational interviewing is provided to participants at baseline and a booster session incorporating personalized feedback is provided at one month
Brief InterventionBehavioural
A brief drug use intervention based on motivational interviewing is provided to participants at baseline
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | 30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk. Receives: Behavioral: Brief Intervention |
| Brief advice | Active comparator | This condition of the experiment acts a control and will be a short session in which the therapist will provide brief advice about drug use and give the patient a pamphlet. Receives: Behavioral: Brief advice |
| Brief Intervention plus Booster | Experimental | 30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk plus a brief phone booster session at 1 month post-intake to review feedback, 2) assess progress, 2) renew motivation to change, and 3) evaluate and affirm commitment to change. Receives: Behavioral: Brief Intervention plus Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest will be patients' subsequent drug use.
Measured: 3, 6, and 12 months after intervention
Secondary outcomes (1)
HIV risk-behaviors, improved health, increased employment, decreased illegal behavior, increased substance treatment, enhanced quality of life, use of Transtheoretical model of change, organization implementation, and intervention cost-effectiveness.
Measured: 3, 6, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mary M Velasquez, PhD, Principal investigator, University of Texas at AustinCraig A Field, PhD, Principal investigator, University of Texas, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048359
- Sponsor's protocol ID
- DESPR DA026088
- Other IDs
- 5R01DA026088-02
- Status last verified
- Nov 2015
- First submitted
- 11 Jan 2010
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to Reduce Injury and Substance Abuse
- ClinicalTrials.gov ID
- NCT01048359
- Acronym / sponsor ID
- DESPR DA026088
- Conditions
- Drug Abuse
- Keywords
- Drug abuse, injury, trauma, screening, brief intervention.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jan 2010 (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 primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who abuse drugs and present to a trauma department for treatment of an injury.
Detailed description
Multidisciplinary Approach to Reduce Injury and Substance Abuse is a randomized clinical trial evaluating the effectiveness of brief advice (BA), brief motivational intervention with feedback (BMI), and brief motivational intervention with feedback and booster (BMI+B) in injured patients with drug problems.
The setting is a level 1 Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive toxicology screen or self reported drug use in the past 90 days. The primary outcome of interest will be patients' subsequent drug use. Other outcomes of interest include: HIV-related risk behaviors, improved health outcomes (including injury reduction), increased employment, decreased engagement in illegal behavior, increased substance abuse treatment utilization, and enhanced quality of life at three, six, and twelve month follow-ups.
This study will also examine the potential moderating and mediating effects of patient readiness to change, use of experiential and behavioral processes of change and decisional balance considerations. In addition, this project will examine implementation factors at the organizational level and the cost effectiveness of BA, BMI, and BMI+B.
Study participants and their related identifying information will be collected during the time they are admitted to the recruitment hospital trauma department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the recruitment hospital trauma department, and test positive for illegal drugs or admit to illegal drug use when verbally screened. Additional information will be collected from participants in the in-person assessment interviews at three, six, and 12 month follow-up periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Brief Intervention30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk. |
| Brief advice | Active comparator | Behavioral: Brief adviceThis condition of the experiment acts a control and will be a short session in which the therapist will provide brief advice about drug use and give the patient a pamphlet. |
| Brief Intervention plus Booster | Experimental | Behavioral: Brief Intervention plus Booster30-45 minute motivational interviewing based intervention with feedback addressing drug use, injury prevention and HIV risk plus a brief phone booster session at 1 month post-intake to review feedback, 2) assess progress, 2) renew motivation to change, and 3) evaluate and affirm commitment to change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Study participants must be 18 years or older
- Speak English or Spanish
- Been admitted to the level 1 Trauma Department
- Test positive for illegal drugs or admit to illegal drug use
Key exclusion criteria (3 listed)
- Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites
- Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15
- Patients who do not pass the Mini-Mental Status Exam are excluded
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 |
|---|---|---|
| Brief adviceThe American College of Surgeons (ACS) recently mandated standards of care for all level I trauma centers and currently defined standards of care at the collaborating institution requires that assessment and referral are included in treatment as usual. Therefore, our treatment as usual, or BA, consists of an initial interview conducted by study staff, a recommendation to abstain from drug use, provision of educational material supporting that recommendation, referral to hospital or community treatment resources most likely to be beneficial to the patient and information about relevant community health care agencies. | Behavioural | Brief advice |
| Brief Intervention plus BoosterA brief drug use intervention based on motivational interviewing is provided to participants at baseline and a booster session incorporating personalized feedback is provided at one month | Behavioural | Brief Intervention plus Booster |
| Brief InterventionA brief drug use intervention based on motivational interviewing is provided to participants at baseline | Behavioural | Brief Intervention |
Primary outcome
The primary outcome of interest will be patients' subsequent drug use.
Time frame: 3, 6, and 12 months after intervention
1 secondary outcome
HIV risk-behaviors, improved health, increased employment, decreased illegal behavior, increased substance treatment, enhanced quality of life, use of Transtheoretical model of change, organization implementation, and intervention cost-effectiveness.
Time frame: 3, 6, and 12 months after 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 25 Nov 2015.
Related trials for Drug Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
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.
Mary M Velasquez, PhD principal investigator
University of Texas at Austin
Craig A Field, PhD principal investigator
University of Texas, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief advice, Brief Intervention plus Booster and Brief Intervention in people with Drug Abuse, run by University of Texas at Austin 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 4 inclusion and 3 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 25 Nov 2015. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
The primary outcome of interest will be patients' subsequent drug use. (time frame: 3, 6, and 12 months after intervention). 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 25 Nov 2015.