Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Brief 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.
Condition or Disease
- Sedative Abuse
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 20 (ESTIMATED) |
| Funded by: | Industry|Other |
| Allocation: | Non-Randomized |
| Primary Purpose: | Prevention |
Masking |
|
Clinical Trial Dates
| Start date: | Aug 01, 2003 | |
|---|---|---|
| Primary Completion: | Aug 30, 2020 | |
| Completion Date: | Mar 01, 2005 | |
| Study First Posted: | Apr 16, 2003 | ESTIMATED |
| Results First Posted: | Aug 30, 2020 | |
| Last Updated: | Sep 09, 2008 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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.
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 Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
-
Pharmacokinetics
More Details
| NCT Number: | NCT00058955 |
|---|---|
| Other IDs: | OMC-SXB-25 |
| Study URL: | https://clinicaltrials.gov/study/NCT00058955 |
Last updated: Sep 29, 2023