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

This study has been terminated.
(Unable to recruit adaquate number of GHB dependent subjects)
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00123578
First received: July 22, 2005
Last updated: November 19, 2008
Last verified: November 2008
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Karen Miotto, M.D. University of California, Los Angeles
  More Information

Additional Information:
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
Chemically-Induced Disorders
Mental Disorders
Lorazepam
Pentobarbital
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on July 31, 2014