Back to resultsPhase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
Primary Purpose
Anxiety Disorder, Panic Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alprazolam
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
Eligibility 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
Sites / Locations
- University of Texas Health Science Center at San Antonio
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004373
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00004373
Brief Title
Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Panic Disorder
Keywords
anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alprazolam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Roache
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9179516
Citation
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. doi: 10.1016/s0376-8716(97)01354-9.
Results Reference
background
Citation
Roache JD, Stanley MA: Diazepam reinforcement in anxious patients. Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.
Results Reference
background
Learn more about this trial
Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
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