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

NCT00004373 | Completed Phase 2

• 2 other identifiers: 199/11960UTHSC-92120
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Panic Disorder

Keywords

anxiety disorder; disease-related problem/condition; neurologic and psychiatric disorders; panic disorder; rare disease

Interventions

alprazolam DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• University of Texas: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Related Publications (2)

• 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.

  PMID: 9179516 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John D. Roache

  University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: March 1, 1997
• Study Completion: March 1, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-05

Locations

US (1)