Alcohol AbusePhase 3NCT00244049
CHIPs or College Health Intervention Projects
A Phase 3 study testing counseling and Brief Intervention in people with Alcohol Abuse, run by University of Wisconsin, Madison.
Trial summary
The goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- counseling and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Apr 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview
Who cannot join
- Students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention Female students who are pregnant at the time of randomization Students who are currently suicidal at the time of the baseline interview Students under 18 years of age Students who drink more than 200 drinks in 28 days (referred for treatment).
About this study
Official title: "Primary Care Alcohol Intervention in College Students"
The goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.
- Conditions
- Alcohol Abuse
- Being tested
- counseling, Brief Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingBehavioural
Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.
Brief InterventionOther
Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.
| Study group | Role | What they receive |
|---|---|---|
| Brief clinician advice | Experimental | Not described Receives: Behavioral: counseling; Other: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in binge/high-risk drinking in college-aged students.
Measured: 6-months
Secondary outcomes (1)
c) fr. of accidents, d) fr. of campus vandalism and interaction police; e) academic perf; f) fr. of unwanted sex; g) fr. of high-risk sex; h) fr. of physical altercations i) ER visits and hospital days; and j) cost vs. benefit of the intervention.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startMay 2004
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Michael Fleming, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244049
- Sponsor's protocol ID
- 1R01AA014685-01
- Other IDs
- 1R01AA014685-01
- Status last verified
- Dec 2014
- First submitted
- 21 Oct 2005
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Primary Care Alcohol Intervention in College Students"
- ClinicalTrials.gov ID
- NCT00244049
- Acronym / sponsor ID
- 1R01AA014685-01
- Conditions
- Alcohol Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Oct 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 goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief clinician advice | Experimental | Behavioral: counseling, Other: Brief Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview
Key exclusion criteria (1 listed)
- Students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention Female students who are pregnant at the time of randomization Students who are currently suicidal at the time of the baseline interview Students under 18 years of age Students who drink more than 200 drinks in 28 days (referred for treatment).
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 |
|---|---|---|
| counselingPhysicians discussed high-risk/binge drinking with college-aged individuals in a health care setting. | Behavioural | Brief clinician advice |
| Brief InterventionPhysicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting. | Other | Brief clinician advice |
Primary outcome
Reduction in binge/high-risk drinking in college-aged students.
Time frame: 6-months
1 secondary outcome
c) fr. of accidents, d) fr. of campus vandalism and interaction police; e) academic perf; f) fr. of unwanted sex; g) fr. of high-risk sex; h) fr. of physical altercations i) ER visits and hospital days; and j) cost vs. benefit of the intervention.
Time frame: 6-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 8 Dec 2014.
Related trials for Alcohol Abuse
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
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
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
Not yet recruitingPhase 1
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
Psilocybin Intoxication
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 Fleming, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing counseling and Brief Intervention in people with Alcohol Abuse, run by University of Wisconsin, Madison.
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: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in binge/high-risk drinking in college-aged students. (time frame: 6-months). 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 Dec 2014.