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

Panic Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004373
• Other study ID #: 199/11960
• Secondary ID: UTHSC-92120
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: March 1997
• Est. completion date: March 2001

Study information

• Verified date: May 2003
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Disease
• Panic Disorder

Intervention

Drug:
• alprazolam

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (2)

Roache JD, Stanley MA, Creson DR, Shah NN, Meisch RA. Alprazolam-reinforced medication use in outpatients with anxiety. Drug Alcohol Depend. 1997 May 2;45(3):143-55. — View Citation

Roache JD, Stanley MA: Diazepam reinforcement in anxious patients. Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.