Alcohol Consumption — Southern Methodist Alcohol Research Trial (SMART)
Citation(s)
Harris TR, Walters ST, Leahy MM Readiness to change among a group of heavy-drinking college students: correlates of readiness and a comparison of measures. J Am Coll Health. 2008 Nov-Dec;57(3):325-30. doi: 10.3200/JACH.57.3.325-330.
Roudsari BS, Leahy MM, Walters ST Correlates of dating violence among male and female heavy-drinking college students. J Interpers Violence. 2009 Nov;24(11):1892-905. doi: 10.1177/0886260508325492. Epub 2008 Nov 3.
Walters ST, Roudsari BS, Vader AM, Harris TR Correlates of protective behavior utilization among heavy-drinking college students. Addict Behav. 2007 Nov;32(11):2633-44. Epub 2007 Jun 29.
Walters ST, Vader AM, Harris TR, Field CA, Jouriles EN Dismantling motivational interviewing and feedback for college drinkers: a randomized clinical trial. J Consult Clin Psychol. 2009 Feb;77(1):64-73. doi: 10.1037/a0014472.
Dismantling Motivational Interviewing and Feedback for College Drinkers
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
