GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
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|ClinicalTrials.gov Identifier: NCT00123578|
Recruitment Status : Withdrawn (Unable to recruit adaquate number of GHB dependent subjects)
First Posted : July 25, 2005
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders||Drug: Lorazepam Drug: Pentobarbital||Phase 1 Phase 2|
GHB and GHB precursors such as 1,4-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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||GHB: Effects, Withdrawal and Treatment|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Lorazepam for the treatment of mild GHB withdrawal.
Other Name: Ativan
Active Comparator: Pentobarbital
Pentobarbital for the treatment of mild GHB withdrawal.
Other Name: Nembuta
- Subjective withdrawl symptoms measures using CIWA scale [ Time Frame: daily during medical administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123578
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Karen Miotto, M.D.||University of California, Los Angeles|