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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00123578

Purpose

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.

Condition	Intervention	Phase
Sodium Oxybate Substance-Related Disorders	Drug: Lorazepam Drug: Pentobarbital	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	GHB: Effects, Withdrawal and Treatment

Resource links provided by NLM:

MedlinePlus related topics: Club Drugs Drug Abuse

Drug Information available for: Pentobarbital sodium Pentobarbital Lorazepam

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Subjective withdrawl symptoms measures, Days 1 through 14 [ Time Frame: study terminated ] [ Designated as safety issue: Yes ]

Enrollment:	5
Study Start Date:	August 2004
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Lorazepam Lorazepam Other Name: Ativan Drug: Pentobarbital Pentobarbital Other Name: Nembuta

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123578

Locations

United States, California
UCLA
Los Angeles, California, United States, 90095

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Karen Miotto, M.D.

University of California, Los Angeles

More Information

Additional Information:

UCLA GHB Research Study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Karen Miotto, M.D., UCLA Neuropsychiatric Institute
ClinicalTrials.gov Identifier:	NCT00123578 History of Changes
Other Study ID Numbers:	NIDA-14291-1, K23-14291-1, DPMC
Study First Received:	July 22, 2005
Last Updated:	November 19, 2008
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders
Lorazepam
Pentobarbital
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents

Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 09, 2012