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

Primary Purpose

Substance-Related Disorders

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorazepam
Pentobarbital
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lorazepam

Pentobarbital

Arm Description

Lorazepam for the treatment of mild GHB withdrawal.

Pentobarbital for the treatment of mild GHB withdrawal.

Outcomes

Primary Outcome Measures

Subjective withdrawl symptoms measures using CIWA scale

Secondary Outcome Measures

Full Information

First Posted
July 22, 2005
Last Updated
May 10, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00123578
Brief Title
GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
Official Title
GHB: Effects, Withdrawal and Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit adaquate number of GHB dependent subjects
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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, 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorazepam
Arm Type
Experimental
Arm Description
Lorazepam for the treatment of mild GHB withdrawal.
Arm Title
Pentobarbital
Arm Type
Active Comparator
Arm Description
Pentobarbital for the treatment of mild GHB withdrawal.
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
Lorazepam
Intervention Type
Drug
Intervention Name(s)
Pentobarbital
Other Intervention Name(s)
Nembuta
Intervention Description
Pentobarbital
Primary Outcome Measure Information:
Title
Subjective withdrawl symptoms measures using CIWA scale
Time Frame
daily during medical administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Miotto, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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