NCT00004373

Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety Disorder
• Panic Disorder

Interventions

Type	Name	Description
DRUG	alprazolam

Timeline

• Start date: 1997-03-01
• Completion: 2001-03-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States