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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004373
Enrollment
80
Registered
1999-10-19
Start date
1997-03-31
Completion date
2001-03-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder, Panic Disorder

Keywords

anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease

Brief 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.

Interventions

DRUGalprazolam

Sponsors

University of Texas
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026