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


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Alprazolam

Xanax 




Clinical Trial: Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients with Anxiety

This study has been completed.

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Texas
Information provided by: Office of Rare Diseases (ORD)

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 Treatment or Intervention Phase
Anxiety Disorder
Panic Disorder
 Drug: alprazolam
Phase II

MedlinePlus related topics:  Anxiety;   Panic Disorder

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  80

Study start: March 1997;  Study completion: March 2001

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   -   50 Years,  Genders Eligible for Study:  Both

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

Location Information


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

Study chairs or principal investigators

John D. Roache,  Study Chair,  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
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004373
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 26, 2009



Page Updated: October 3, 2005
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