Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123578
Status:
WITHDRAWN
Last Update Posted:
2016-05-12
First Post:
2005-07-22
Brief Title:
GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
GHB Effects Withdrawal and Treatment
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit adaquate number of GHB dependent subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gamma hydroxybutyrate GHB is a powerful central nervous system depressant The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States Currently lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification
Detailed Description:
GHB and GHB precursors such as 14-butanediol and gamma-butylrolactone GBL have become popular drugs of abuse In cases of severe withdrawal delirium confusion hallucinations and agitation can occur There has been a sharp rise in the number of GHB related emergency room visits over the past few years yet little is known about the effective treatment of GHB withdrawal and dependence The purpose of this study is to describe the signs and symptoms of GHB withdrawal identify predictors of withdrawal severity and evaluate the safety and effectiveness of treatment for GHB detoxification There will be compensation for screening assessments
The study includes two phases The open-label Phase 1 will aim to determine the safety of lorazepam for the treatment of mild GHB withdrawal Participants who progress into moderate or severe withdrawal will enter the controlled Phase 2 In Phase 2 participants will be randomly assigned to receive either lorazepam or pentobarbital in order to determine which drug is more effective in treating GHB withdrawal
The study will consist of 1 to 2 outpatient screening visits followed by up to 15 days of inpatient detoxification treatment and assessment After hospital discharge from inpatient treatment measures of protracted GHB withdrawal and psychiatric symptoms will be obtained on an outpatient weekly basis for 8 weeks Repeat measures of cognitive functioning will be obtained at baseline termination of treatment and at 30 60 and 90-day follow-up intervals in order to assess long-term neurocognitive effects of GHB withdrawal and use
The study includes two phases The open-label Phase 1 will aim to determine the safety of lorazepam for the treatment of mild GHB withdrawal Participants who progress into moderate or severe withdrawal will enter the controlled Phase 2 In Phase 2 participants will be randomly assigned to receive either lorazepam or pentobarbital in order to determine which drug is more effective in treating GHB withdrawal
The study will consist of 1 to 2 outpatient screening visits followed by up to 15 days of inpatient detoxification treatment and assessment After hospital discharge from inpatient treatment measures of protracted GHB withdrawal and psychiatric symptoms will be obtained on an outpatient weekly basis for 8 weeks Repeat measures of cognitive functioning will be obtained at baseline termination of treatment and at 30 60 and 90-day follow-up intervals in order to assess long-term neurocognitive effects of GHB withdrawal and use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DA014291 | NIH | None | httpsreporternihgovquickSearchK23DA014291 |