Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs.
II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence.
III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients.
IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication.
V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||March 1997|
|Estimated Study Completion Date:||March 2001|
PROTOCOL OUTLINE: This protocol involves different experiments examining self-medication with anxiolytic medications in selected patients, and cognitive-behavioral therapy for anxiety. Capsules are color coded and taken under double-blind conditions. Compliance is monitored with the Medication Event Monitoring System, which automatically registers the date and time each bottle is opened.
The physician directs therapy administration, using some combination of the following: blind choice test, antianxiety agent(s), placebo, and cognitive-behavioral therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004373
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||John D. Roache||University of Texas|