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Home > "P" Clinical Trials Conditions > Physiological, Behavioral and Subjective Effects of Drugs (GHB)  Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Physiological, Behavioral and Subjective Effects of Drugs (GHB)
For Condition: Sedative abuse
Status: Recruiting
Sponsor(s): Orphan Medical , Johns Hopkins University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 20
Location and Contact Information:
Johns Hopkins University School of Medicine/Bayview Medical Center *Recruiting*
Baltimore, Maryland, 21224
United States
Recruiting Roland Griffiths 410-550-0034
Additional Information:
Study ID Numbers: OMC-SXB-25; BPR00-09-27-02
Study Start Date: August 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058955
Other Sedative Abuse Studies:
1. Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Related Studies:
Other Sedative abuse Clinical Trials
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Physiological, Behavioral and Subjective Effects of Drugs (GHB)
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