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WithdrawnNCT00123578Updated May 12, 2016

GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1

A Phase 1/2 interventional study of Lorazepam and Pentobarbital in Substance-Related Disorders, sponsored by University of California, Los Angeles. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by University of California, Los Angeles · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Unable to recruit adaquate number of GHB dependent subjects
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Substance-Related Disorders
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

Browse Substance-Related Disorders studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meets DSM-IV criteria for GHB dependence
  • Self-reported as GHB dependent with current daily use of GHB
  • Use of GHB for at least 20 consecutive days prior to enrollment
  • Desire to stop GHB use
  • Availability of a friend or family member to act as a collateral informant
  • Speaks and understands English

Exclusion criteria

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, or do not agree to use adequate forms of contraception
  • History of seizures
  • A baseline EEG of clinical concern that requires inpatient ICU detoxification
  • Any anticonvulsant therapy during the 3 years prior to enrollment
  • Pancreatic disease, such as insulin-dependent diabetes
  • Liver disease that requires medication or medical treatment
  • Gastrointestinal or kidney disease that might significantly impair absorption, metabolism, or excretion of study drug, or might require medication or medical treatment
  • Asthma, hives, angioedema, or similar condition
  • Acute intermittent porphyria or porphyria variegata
  • Neurological or psychiatric disorders, including psychosis, bipolar disorder, or other disorders that require treatment or might make study compliance difficult (assessed by the Structured Clinical Interview for DSM-IV-TR)
  • Positive tuberculosis (PPD) skin test with a clinical history and chest X-ray indicative of active tuberculosis (individuals with a positive PPD test and a negative chest X-ray, who are not symptomatic for tuberculosis and do not require antituberculosis therapy, will be eligible to participate)
  • Clinically significant abnormal baseline EKG
  • Requirement for any of the following medications currently or within the 4 weeks prior to enrollment: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics, anticonvulsants, antihypertensives, antiarrhythmics, or antiretroviral medications
  • Nicotine dependent participants will be given nicotine patch therapy for the duration of the study; participants who refuse nicotine patch therapy will continue in the study as determined by the hospital smoking and standard of care regulations
  • Meets DSM-IV criteria for dependence on any psychoactive substance other than GHB, caffeine, or nicotine
  • Symptomatic HIV infection
  • Alcohol breath test greater than .05 ppm at time of hospital admission
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Lorazepam

    Lorazepam for the treatment of mild GHB withdrawal.

    Drug: Lorazepam

  • Active comparator
    Pentobarbital

    Pentobarbital for the treatment of mild GHB withdrawal.

    Drug: Pentobarbital

Interventions

  • DrugLorazepam

    Lorazepam

    Also known as: Ativan

  • DrugPentobarbital

    Pentobarbital

    Also known as: Nembuta

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What researchers measure

Primary outcomes

  1. Subjective withdrawl symptoms measures using CIWA scale

    Time frame: daily during medical administration

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Study locations

1 site
  • UCLA
    Los Angeles, California 90095, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00123578
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Karen Miotto (Clinical Professor, University of California, Los Angeles) — Principal investigator
First posted
Jul 25, 2005
Start date
Aug 2004
Primary completion
Aug 2008
Completion
Aug 2008
Last update
May 12, 2016

Study contacts

Karen Miotto, M.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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