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

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004373
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: May 2003
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00004373     History of Changes
Other Study ID Numbers: 199/11960, UTHSC-92120
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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:
Anxiety Disorders
Panic Disorder
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013