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.

Condition	Treatment or Intervention	Phase
Sedative abuse	Drug: sodium oxybate, triazolam and pentobarbital	Phase I

Further Study Details: 

Expected Total Enrollment:  20

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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Roland R Griffiths, PhD      410-550-0034    rgriff@jhmi.edu

Maryland
      Johns Hopkins University School of Medicine/Bayview Medical Center, Baltimore,  Maryland,  21224,  United States; Recruiting

Study ID Numbers:  OMC-SXB-25; BPR00-09-27-02
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  April 15, 2003
ClinicalTrials.gov Identifier:  NCT00058955
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08