CHIPs or College Health Intervention Projects

Alcohol Abuse Clinical Trial

Official title:

"Primary Care Alcohol Intervention in College Students"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244049
• Other study ID #: 1R01AA014685-01
• Secondary ID: 1R01AA014685-01
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2005
• Last updated: December 5, 2014
• Start date: May 2004
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Behavioral:
• counseling
Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.

Other:
• Brief Intervention
Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in binge/high-risk drinking in college-aged students.		6-months	No
Secondary	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.		6-months	No