Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Orphan Medical

Status and phase: Completed; Phase 1

Conditions: Sedative Abuse

Treatments: Drug: sodium oxybate, triazolam and pentobarbital

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00058955

BPR00-09-27-02

OMC-SXB-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Sodium oxybate

Treatment:

Drug: sodium oxybate, triazolam and pentobarbital

2

Active Comparator group

Description:

triazolam

Treatment:

Drug: sodium oxybate, triazolam and pentobarbital

3

Active Comparator group

Description:

pentobarbital

Treatment:

Drug: sodium oxybate, triazolam and pentobarbital

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: sodium oxybate, triazolam and pentobarbital