Status:
WITHDRAWN
GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Substance-Related Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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, lor...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00123578
Start Date
August 1 2004
End Date
August 1 2008
Last Update
May 12 2016
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095