Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorder; Panic Disorder
Intervention: alprazolam (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
John D. Roache, Study Chair, Affiliation: University of Texas
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.
Clinical Details
Study design: Treatment
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): 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
Locations and Contacts
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States
Additional Information
Related 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.
Starting date: March 1997
Ending date: March 2001
Last updated: June 23, 2005
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