Substance-Related DisordersPhase 1/2NCT00123578
GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
A Phase 1/2 study testing Lorazepam and Pentobarbital in people with Substance-Related Disorders, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Lorazepam and Pentobarbital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2008
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV criteria for GHB dependence
- Self-reported as GHB dependent with current daily use of GHB
- Use of GHB for at least 20 consecutive days prior to enrollment
- Desire to stop GHB use
- Availability of a friend or family member to act as a collateral informant
- Speaks and understands English
Who cannot join
- Females who are pregnant, breastfeeding, or do not agree to use adequate forms of contraception
- History of seizures
- A baseline EEG of clinical concern that requires inpatient ICU detoxification
- Any anticonvulsant therapy during the 3 years prior to enrollment
- Pancreatic disease, such as insulin-dependent diabetes
- Liver disease that requires medication or medical treatment
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- Gastrointestinal or kidney disease that might significantly impair absorption, metabolism, or excretion of study drug, or might require medication or medical treatment
- Asthma, hives, angioedema, or similar condition
- Acute intermittent porphyria or porphyria variegata
- Neurological or psychiatric disorders, including psychosis, bipolar disorder, or other disorders that require treatment or might make study compliance difficult (assessed by the Structured Clinical Interview for DSM-IV-TR)
- Positive tuberculosis (PPD) skin test with a clinical history and chest X-ray indicative of active tuberculosis (individuals with a positive PPD test and a negative chest X-ray, who are not symptomatic for tuberculosis and do not require antituberculosis therapy, will be eligible to participate)
- Clinically significant abnormal baseline EKG
- Requirement for any of the following medications currently or within the 4 weeks prior to enrollment: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics, anticonvulsants, antihypertensives, antiarrhythmics, or antiretroviral medications
- Nicotine dependent participants will be given nicotine patch therapy for the duration of the study; participants who refuse nicotine patch therapy will continue in the study as determined by the hospital smoking and standard of care regulations
- Meets DSM-IV criteria for dependence on any psychoactive substance other than GHB, caffeine, or nicotine
- Symptomatic HIV infection
- Alcohol breath test greater than .05 ppm at time of hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GHB: Effects, Withdrawal and Treatment
Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.
Read the detailed description
GHB and GHB precursors such as 1,4-butanediol and gamma-butylrolactone (GBL) have become popular drugs of abuse. In cases of severe withdrawal, delirium, confusion, hallucinations, and agitation can occur. There has been a sharp rise in the number of GHB related emergency room visits over the past few years, yet little is known about the effective treatment of GHB withdrawal and dependence. The purpose of this study is to describe the signs and symptoms of GHB withdrawal, identify predictors of withdrawal severity, and evaluate the safety and effectiveness of treatment for GHB detoxification. There will be compensation for screening assessments.
The study includes two phases. The open-label Phase 1 will aim to determine the safety of lorazepam for the treatment of mild GHB withdrawal. Participants who progress into moderate or severe withdrawal will enter the controlled Phase 2. In Phase 2, participants will be randomly assigned to receive either lorazepam or pentobarbital in order to determine which drug is more effective in treating GHB withdrawal.
The study will consist of 1 to 2 outpatient screening visits, followed by up to 15 days of inpatient detoxification treatment and assessment. After hospital discharge from inpatient treatment, measures of protracted GHB withdrawal and psychiatric symptoms will be obtained on an outpatient weekly basis for 8 weeks. Repeat measures of cognitive functioning will be obtained at baseline, termination of treatment, and at 30, 60, and 90-day follow-up intervals in order to assess long-term neurocognitive effects of GHB withdrawal and use.
- Conditions
- Substance-Related Disorders
- Being tested
- Lorazepam, Pentobarbital
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Also called Ativan
Lorazepam
PentobarbitalDrug
Also called Nembuta
Pentobarbital
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam | Experimental | Lorazepam for the treatment of mild GHB withdrawal. Receives: Drug: Lorazepam |
| Pentobarbital | Active comparator | Pentobarbital for the treatment of mild GHB withdrawal. Receives: Drug: Pentobarbital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective withdrawl symptoms measures using CIWA scale
Measured: daily during medical administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Unable to recruit adaquate number of GHB dependent subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Karen Miotto, University of California, Los Angeles
- Investigators
- Karen Miotto, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123578
- Sponsor's protocol ID
- NIDA-14291-1
- Other IDs
- K23DA014291
- Status last verified
- May 2016
- First submitted
- 22 Jul 2005
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GHB: Effects, Withdrawal and Treatment
- ClinicalTrials.gov ID
- NCT00123578
- Acronym / sponsor ID
- NIDA-14291-1
- Conditions
- Substance-Related Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit adaquate number of GHB dependent subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 25 Jul 2005 (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.
Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.
Detailed description
GHB and GHB precursors such as 1,4-butanediol and gamma-butylrolactone (GBL) have become popular drugs of abuse. In cases of severe withdrawal, delirium, confusion, hallucinations, and agitation can occur. There has been a sharp rise in the number of GHB related emergency room visits over the past few years, yet little is known about the effective treatment of GHB withdrawal and dependence. The purpose of this study is to describe the signs and symptoms of GHB withdrawal, identify predictors of withdrawal severity, and evaluate the safety and effectiveness of treatment for GHB detoxification. There will be compensation for screening assessments.
The study includes two phases. The open-label Phase 1 will aim to determine the safety of lorazepam for the treatment of mild GHB withdrawal. Participants who progress into moderate or severe withdrawal will enter the controlled Phase 2. In Phase 2, participants will be randomly assigned to receive either lorazepam or pentobarbital in order to determine which drug is more effective in treating GHB withdrawal.
The study will consist of 1 to 2 outpatient screening visits, followed by up to 15 days of inpatient detoxification treatment and assessment. After hospital discharge from inpatient treatment, measures of protracted GHB withdrawal and psychiatric symptoms will be obtained on an outpatient weekly basis for 8 weeks. Repeat measures of cognitive functioning will be obtained at baseline, termination of treatment, and at 30, 60, and 90-day follow-up intervals in order to assess long-term neurocognitive effects of GHB withdrawal and use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorazepam | Experimental | Drug: LorazepamLorazepam for the treatment of mild GHB withdrawal. |
| Pentobarbital | Active comparator | Drug: PentobarbitalPentobarbital for the treatment of mild GHB withdrawal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Meets DSM-IV criteria for GHB dependence
- Self-reported as GHB dependent with current daily use of GHB
- Use of GHB for at least 20 consecutive days prior to enrollment
- Desire to stop GHB use
- Availability of a friend or family member to act as a collateral informant
Key exclusion criteria (17 listed)
- Females who are pregnant, breastfeeding, or do not agree to use adequate forms of contraception
- History of seizures
- A baseline EEG of clinical concern that requires inpatient ICU detoxification
- Any anticonvulsant therapy during the 3 years prior to enrollment
- Pancreatic disease, such as insulin-dependent diabetes
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 |
|---|---|---|
| LorazepamAlso: AtivanLorazepam | Drug | Lorazepam |
| PentobarbitalAlso: NembutaPentobarbital | Drug | Pentobarbital |
Primary outcome
Subjective withdrawl symptoms measures using CIWA scale
Time frame: daily during medical administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- UCLA GHB Research StudyLink provided by the sponsor.
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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.
Karen Miotto, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lorazepam and Pentobarbital in people with Substance-Related Disorders, run by University of California, Los Angeles 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 6 inclusion and 17 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: withdrawn, as of the sponsor's last update on 12 May 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Subjective withdrawl symptoms measures using CIWA scale (time frame: daily during medical administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.