Physiological, Behavioral and Subjective Effects of Drugs... | NCT00058955

Studies
Physiological, Behavioral and Subjective Effects of Drugs (GHB)

NCT00058955

Sponsor

Orphan Medical

Status

Completed

Last Update Posted

Sep 10, 2008Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Sedative Abuse

Interventions

sodium oxybate, triazolam and pentobarbital

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BPR00-09-27-02

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005

First Submitted Date

Apr 15, 2003

First Submission Date that Met QC Criteria

Apr 15, 2003

First Posted Date

Apr 16, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2008

Last Update Posted Date

Sep 10, 2008Estimated

Name	Class
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid (GHB) by comparing its physiological, behavioral and subjective effects with those of several other drugs.

Detailed Description

The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid by comparing its physiological, behavioral and subjective effects with those of several other drugs.

This trial will be conducted as a double-blind, double-dummy, placebo-controlled, counter-balanced (Latin-square design) crossover study in volunteers with histories of sedative abuse. Volunteers will be recruited through advertising and word-of-mouth.

Volunteers will reside on our residential research unit for the duration of the study and participate in a maximum of 16 experimental sessions. Sessions will be conducted five days a week (Monday through Friday). The primary subjective and behavioral measures will be taken before drug administration and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after drug administration.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Sodium oxybate	Drug: sodium oxybate, triazolam and pentobarbital
2	Active Comparator	triazolam	Drug: sodium oxybate, triazolam and pentobarbital
3	Active Comparator	pentobarbital	Drug: sodium oxybate, triazolam and pentobarbital
4	Placebo Comparator	Placebo	Drug: sodium oxybate, triazolam and pentobarbital

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium oxybate, triazolam and pentobarbital	Drug	sodium oxybate, triazolam and pentobarbital	1 2 3 4

Measure	Description	Time Frame
Pharmacokinetics

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

are ages 18-50 years
have histories of sedative (e.g., GHB, alcohol, benzodiazepine or barbiturate) abuse
are within 20% of their ideal body weight
are healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, and routine medical blood and urinalysis laboratory tests
are not currently pregnant or breast-feeding, if female
have signed and dated an informed consent form prior to beginning the study
are willing and able to participate

EXCLUSION CRITERIA

have a history or current serious medical or psychiatric conditions, including (but not limited to): heart condition, lung disease, diabetes, seizure disorders, significant gastrointestinal disturbances, narrow angle glaucoma, ulcers, sleep apnea, schizophrenia, personality disorder, bipolar disorder, paranoia, multiple personality disorder
have hypersensitivity/allergy or other contraindications to sedatives or stimulants
are physically dependent on alcohol or other drugs, excluding nicotine and caffeine
are females who are pregnant or are breast feeding
are females who become pregnant during the study as evaluated using periodic pregnancy tests

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland Griffiths, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University School of Medicine/Bayview Medical Center		Baltimore	Maryland	21224	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12627729	Background	A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
11833860	Background	A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

ID	Term
D012978	Sodium Oxybate
D014229	Triazolam
D010424	Pentobarbital

ID	Term
D006885	Hydroxybutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids