Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Completed · Phase 1

Conditions studied: Sedative Abuse

In brief

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.

Key facts

Study ID

NCT00058955

Run by

Orphan Medical

People needed

20

Starts

2003-08-01

Expected to finish

2005-03-01

Last updated by the study team

2008-09-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University School of Medicine/Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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