Self-Medication with Alprazolam in Anxiety Patients: Double-Blind Study
This phase 2 study aims to evaluate the effectiveness of self-medication with Alprazolam as a treatment for individuals experiencing anxiety.
alprazolam
Nervous System Diseases+7
+ Pathologic Processes
+ Signs and Symptoms
Treatment Study
Summary
Study start date: March 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Primary diagnosis of generalized anxiety or panic disorder Determined by Structured Clinical Interview for DSM IV Hamilton Anxiety Scale (HAM-A) score at least 14 AND Profile of Mood States (POMS) tension/anxiety scale score at least 20 Concurrent diagnoses allowed: Mild to moderate agoraphobia Simple or social phobias Secondary unipolar affective disorders No current substance abuse, dependence, or substance abuse treatment Drug-free urine sample required No history of other primary Axis I diagnosis other than tobacco dependence --Prior/Concurrent Therapy-- No prior formalized non-drug therapy for anxiety disorder No concurrent prescription psychoactive medication No history of benzodiazepine dependence --Patient Characteristics-- Age: 18 to 50 Other: Medically healthy Negative pregnancy test required No occupational requirement to work in hazardous situations
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas Health Science Center at San Antonio
San Antonio, United StatesOpen University of Texas Health Science Center at San Antonio in Google Maps