Drug AbuseNCT00251173
Project Health Link: Connecting Patients With Services
A study testing Strengths Based Case Management (SBCM), Motivational Enhancement Therapy (MET) and Brief Informational Feedback (BIF) session in people with Drug Abuse, run by University of Michigan at 1 site in United States.
Trial summary
The proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Strengths Based Case Management (SBCM), Motivational Enhancement Therapy (MET) and Brief Informational Feedback (BIF) session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 755 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2009
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) adults age 19-60 presenting to the Hurley Medical Center ED within 24 hours of an injury; (2) ability to provide informed consent.
- Additional inclusion criteria for intervention study: meets criteria for substance abuse or dependence for stimulants (cocaine powder, crack cocaine, methamphetamine, amphetamine), cannabis (marijuana, hashish), and or opioids (noninjected heroin, other opioids such as hydrocodone and oxycodone) in the previous year.
Who cannot join
- (1) adult patients who do not understand English; (2) prisoners; (3) adults classified by medical staff as "Level 1 trauma"; (4) adults deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence); (5) patients treated in the ED for suicide attempts and sexual assaults; (6) patients who have been in treatment for substance abuse in the past six months; (7) patients who are triaged to psychiatric emergency services; and (8) patients who report injecting heroin or other opiates in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Services Interventions for Injured ED Substance Abusers
The proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary outcome variables for this trial include receiving an assessment and referral and treatment entry. Other outcomes include degree of treatment completion, substance-related measures, health service utilization, health status changes, and psychosocial factors.
- Conditions
- Drug Abuse
- Being tested
- Strengths Based Case Management (SBCM), Motivational Enhancement Therapy (MET), Brief Informational Feedback (BIF) session
- 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 Management (SBCM)Behavioural
Motivational Enhancement Therapy (MET)Behavioural
Brief Informational Feedback (BIF) sessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Strengths Based Case Management Model (SBCM) | Active comparator | The Strengths Based Case Management Model (SBCM) consists of 5 case-management sessions designed to promote linkage and engagement in assessment and treatment services, while assisting with the patient's perceived needs, as well as personal strengths and barriers to linkage and engagement. Receives: Behavioral: Strengths Based Case Management (SBCM) |
| Motivational Enhancement Therapy (MET) | Active comparator | The MET therapist will conduct 2 motivational enhancement sessions to work through the content of an educational workbook targeting the participant's substance use/abuse with the goal of negotiating a 'contract' to: 1) link to services, with the eventual goal of seeking and receiving specialized substance treatment; or 2) provide a strategy to self-monitor substance use, consider consequences, and later seek assessment. Receives: Behavioral: Motivational Enhancement Therapy (MET) |
| Brief Informational Feedback (BIF) session | Active comparator | Subjects will receive brief informational feedback on the results of their alcohol screening and assessment and encouragement to seek treatment. Receives: Behavioral: Brief Informational Feedback (BIF) session |
What is being measured
The primary outcome is the main question the study is designed to answer.
receipt of assessment
Measured: 3 and 6 months post-baseline
treatment entry
Measured: 3 and 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2009
- Study completionDec 2009
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 MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic C. Blow, University of Michigan
- Investigators
- Frederic C Blow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251173
- Sponsor's protocol ID
- 1R01DA016591-01A1
- Status last verified
- Apr 2016
- First submitted
- 7 Nov 2005
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Services Interventions for Injured ED Substance Abusers
- ClinicalTrials.gov ID
- NCT00251173
- Acronym / sponsor ID
- 1R01DA016591-01A1
- Conditions
- Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Nov 2005 (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 proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary outcome variables for this trial include receiving an assessment and referral and treatment entry. Other outcomes include degree of treatment completion, substance-related measures, health service utilization, health status changes, and psychosocial factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengths Based Case Management Model (SBCM) | Active comparator | Behavioral: Strengths Based Case Management (SBCM)The Strengths Based Case Management Model (SBCM) consists of 5 case-management sessions designed to promote linkage and engagement in assessment and treatment services, while assisting with the patient's perceived needs, as well as personal strengths and barriers to linkage and engagement. |
| Motivational Enhancement Therapy (MET) | Active comparator | Behavioral: Motivational Enhancement Therapy (MET)The MET therapist will conduct 2 motivational enhancement sessions to work through the content of an educational workbook targeting the participant's substance use/abuse with the goal of negotiating a 'contract' to: 1) link to services, with the eventual goal of seeking and receiving specialized substance treatment; or 2) provide a strategy to self-monitor substance use, consider consequences, and later seek assessment. |
| Brief Informational Feedback (BIF) session | Active comparator | Behavioral: Brief Informational Feedback (BIF) sessionSubjects will receive brief informational feedback on the results of their alcohol screening and assessment and encouragement to seek treatment. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- (1) adults age 19-60 presenting to the Hurley Medical Center ED within 24 hours of an injury; (2) ability to provide informed consent.
- Additional inclusion criteria for intervention study: meets criteria for substance abuse or dependence for stimulants (cocaine powder, crack cocaine, methamphetamine, amphetamine), cannabis (marijuana, hashish), and or opioids (noninjected heroin, other opioids such as hydrocodone and oxycodone) in the previous year.
Key exclusion criteria (1 listed)
- (1) adult patients who do not understand English; (2) prisoners; (3) adults classified by medical staff as "Level 1 trauma"; (4) adults deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence); (5) patients treated in the ED for suicide attempts and sexual assaults; (6) patients who have been in treatment for substance abuse in the past six months; (7) patients who are triaged to psychiatric emergency services; and (8) patients who report injecting heroin or other opiates in the past year.
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 Management (SBCM) | Behavioural | Strengths Based Case Management Model (SBCM) |
| Motivational Enhancement Therapy (MET) | Behavioural | Motivational Enhancement Therapy (MET) |
| Brief Informational Feedback (BIF) session | Behavioural | Brief Informational Feedback (BIF) session |
Primary outcome
receipt of assessment
Time frame: 3 and 6 months post-baseline
treatment entry
Time frame: 3 and 6 months post-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 8 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Frederic C Blow, PhD principal investigator
University of Michigan
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 (SBCM), Motivational Enhancement Therapy (MET) and Brief Informational Feedback (BIF) session in people with Drug Abuse, run by University of Michigan 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 2 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 8 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 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?
receipt of assessment (time frame: 3 and 6 months post-baseline). The study lists 2 primary outcomes in all. 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 8 Apr 2016.