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

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborator: University of Texas
• Treatments: Alprazolam

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