Sedative AbusePhase 1NCT00058955
Physiological, Behavioral and Subjective Effects of Drugs (GHB)
A Phase 1 study testing sodium oxybate, triazolam and pentobarbital in people with Sedative Abuse, run by Orphan Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedative Abuse
- What is being tested?
- sodium oxybate, triazolam and pentobarbital
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine/Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the detailed description
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.
- Conditions
- Sedative Abuse
- Being tested
- sodium oxybate, triazolam and pentobarbital
- Keywords
- ghb, Xyrem, triazolam, pentobarbital, sedative, abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium oxybate, triazolam and pentobarbitalDrug
Also called Xyrem
sodium oxybate, triazolam and pentobarbital
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sodium oxybate Receives: Drug: sodium oxybate, triazolam and pentobarbital |
| 2 | Active comparator | triazolam Receives: Drug: sodium oxybate, triazolam and pentobarbital |
| 3 | Active comparator | pentobarbital Receives: Drug: sodium oxybate, triazolam and pentobarbital |
| 4 | Placebo comparator | Placebo Receives: Drug: sodium oxybate, triazolam and pentobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startAug 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedative AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orphan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Investigators
- Roland Griffiths, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058955
- Sponsor's protocol ID
- OMC-SXB-25
- Other IDs
- BPR00-09-27-02
- Status last verified
- Sep 2008
- First submitted
- 15 Apr 2003
- Last updated
- 10 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
PubMed 12627729A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
PubMed 11833860
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological, Behavioral and Subjective Effects of Drugs (GHB)
- ClinicalTrials.gov ID
- NCT00058955
- Acronym / sponsor ID
- OMC-SXB-25
- Conditions
- Sedative Abuse
- Keywords
- ghb, Xyrem, triazolam, pentobarbital, sedative, abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Orphan MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- Aug 2003
- Study completion
- Mar 2005
- First posted
- 16 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sodium oxybate, triazolam and pentobarbitalSodium oxybate |
| 2 | Active comparator | Drug: sodium oxybate, triazolam and pentobarbitaltriazolam |
| 3 | Active comparator | Drug: sodium oxybate, triazolam and pentobarbitalpentobarbital |
| 4 | Placebo comparator | Drug: sodium oxybate, triazolam and pentobarbitalPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium oxybate, triazolam and pentobarbitalAlso: Xyremsodium oxybate, triazolam and pentobarbital | Drug | 1, 2, 3, 4 |
Primary outcome
Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2008.
- Background: PubMed 12627729A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
- Background: PubMed 11833860A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Griffiths, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sodium oxybate, triazolam and pentobarbital in people with Sedative Abuse, run by Orphan Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00058955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2008; AzTrials last refreshed its copy on 7 Nov 2026.