NCT00123578

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

July 22, 2005

Last Update Submit

May 10, 2016

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Subjective withdrawl symptoms measures using CIWA scale

    daily during medical administration

Study Arms (2)

Lorazepam

EXPERIMENTAL

Lorazepam for the treatment of mild GHB withdrawal.

Drug: Lorazepam

Pentobarbital

ACTIVE COMPARATOR

Pentobarbital for the treatment of mild GHB withdrawal.

Drug: Pentobarbital

Interventions

LorazepamDRUG

Lorazepam

Also known as: Ativan
Lorazepam
PentobarbitalDRUG

Pentobarbital

Also known as: Nembuta
Pentobarbital

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

LorazepamPentobarbital

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Karen Miotto, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 22, 2005

First Posted

July 25, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)