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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Texas |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004373 |
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 II |
| MedlinePlus related topics: | Anxiety Panic Disorder |
| Drug Information available for: | Alprazolam |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 1997 |
| Estimated Study Completion Date: | 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 to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| United States, Texas | |||||
| University of Texas Health Science Center at San Antonio | |||||
| San Antonio, Texas, United States, 78284-7811 | |||||
| National Institute on Drug Abuse (NIDA) |
| University of Texas |
| Study Chair: | John D. Roache | University of Texas |
More Information
|
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.
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Roache JD, Stanley MA: Diazepam reinforcement in anxious patients.
Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.
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| Study ID Numbers: | 199/11960, UTHSC-92120 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004373 |
| Health Authority: | United States: Federal Government |
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