Substance-Related Disorders Clinical Trial
Official title:
GHB: Effects, Withdrawal and Treatment
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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