Physiological, Behavioral and Subjective Effects of Drugs (GHB)

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orphan Medical
• Collaborator: Johns Hopkins University
• Treatments: Pentobarbital; Sodium Oxybate; Triazolam

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