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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Texas
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004373

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorder Panic Disorder	Drug: alprazolam	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	80
Study Start Date:	March 1997
Estimated Study Completion Date:	March 2001

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004373

Locations

United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Texas

Investigators

Study Chair:

John D. Roache

University of Texas

More Information

Publications:

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.

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

Study ID Numbers:	199/11960, UTHSC-92120
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004373 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pharmacologic Actions
Panic Disorder

Pathologic Processes
Alprazolam
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009