This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been withdrawn prior to enrollment.
(Unable to recruit adaquate number of GHB dependent subjects)
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karen Miotto, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00123578
First received: July 22, 2005
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
July 22, 2005
May 10, 2016
August 2004
August 2008   (Final data collection date for primary outcome measure)
Subjective withdrawl symptoms measures using CIWA scale [ Time Frame: daily during medical administration ]
Subjective symptoms measures
Complete list of historical versions of study NCT00123578 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Substance-Related Disorders
  • Drug: Lorazepam
    Lorazepam
    Other Name: Ativan
  • Drug: Pentobarbital
    Pentobarbital
    Other Name: Nembuta
  • Experimental: Lorazepam
    Lorazepam for the treatment of mild GHB withdrawal.
    Intervention: Drug: Lorazepam
  • Active Comparator: Pentobarbital
    Pentobarbital for the treatment of mild GHB withdrawal.
    Intervention: Drug: Pentobarbital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2008
August 2008   (Final data collection date for primary outcome measure)

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:

  • 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00123578
NIDA-14291-1
K23DA014291 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Karen Miotto, University of California, Los Angeles
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Principal Investigator: Karen Miotto, M.D. University of California, Los Angeles
University of California, Los Angeles
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP