Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004373
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Double-Blind Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 agents placebo and cognitive-behavioral therapy
The physician directs therapy administration using some combination of the following blind choice test antianxiety agents placebo and cognitive-behavioral therapy
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTHSC-92120 | None | None | None |