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

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ClinicalTrials.gov Identifier: NCT00004373
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Anxiety Disorder Panic Disorder Drug: alprazolam Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Primary Purpose: Treatment
Study Start Date : March 1997
Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2003

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:
Disease
Anxiety Disorders
Panic Disorder
Mental Disorders
Pathologic Processes
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action