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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2001-03-31

Brief Summary

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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

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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.

Conditions

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Anxiety Disorder Panic Disorder

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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alprazolam

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John D. Roache

Role: STUDY_CHAIR

University of Texas

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 9179516 (View on PubMed)

Roache JD, Stanley MA: Diazepam reinforcement in anxious patients. Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.