Alcohol Withdrawal Syndrome(AWS)Phase 2NCT00229125
Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam
A Phase 2 study testing Gabapentin and Lorazepam in people with Alcohol Withdrawal Syndrome(AWS), run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The purpose of this study was to evaluate if the medication Gabapentin, which is not approved for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal syndrome compared to treatment with Lorazepam. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Withdrawal Syndrome(AWS)
- What is being tested?
- Gabapentin and Lorazepam
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Sep 2005
- Phase
- Phase 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be between 21-70 years of age (both genders will be recruited).
- Subjects must meet DSM-IV criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
- Subjects must have a mini-mental state score above 26.
- Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
- Subjects must have a minimum score on the Clinical Institute Withdrawal - - Assessment for Alcohol-Revised (CIWA-Ar) of 10 within 24 hours of initial assessment.
- Subjects must be medically acceptable for study treatment. Considerations include no past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
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- Subjects must exhibit vital signs within the following range: a three-minute sitting blood pressure in the range of 90-200 mmHg systolic, 60-120 mmHg diastolic and ventricular rates between 56 and 140 beats per minute.
- Subjects must be suitable for treatment with oral medications.
- Subjects must be able to read, write, and speak English.
- Subjects must have a negative urine drug screen for benzodiazepines or other sedative-hypnotics, opiates, and stimulants at baseline.
Who cannot join
- Subjects with current (past month) DSM-IV diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine, caffeine, cannabis and cocaine dependence).
- Use of pharmacological agents within a five half-life period that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome (e.g.,tricyclic antidepressants, anticonvulsants, neuroleptics, benzodiazepines, some centrally-acting antihypertensives such as beta-blockers, alpha-adrenergic agonists, and calcium channel antagonists, wellbutrin, buspar, any sedative-hypnotics and opiates).
- Subjects with a history of idiopathic epilepsy.
- Subjects with diagnosis of schizophrenia, bipolar disorder or dementia.
- Subjects with liver function tests (AST or ALT) 4 times higher than normal. Serum levels will be drawn upon admission to study and study medications terminated if necessary.
- History of hepatic encephalopathy, jaundice, ascites, insulin dependent diabetes, or renal disease.
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- Females who are pregnant (as determined by a pregnancy test) or nursing.
- Subjects with known sensitivity or previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines.
- History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
- Subjects who decline or who are not competent to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina - Center for Drug and Alcohol Programs
Charleston, South Carolina, 29425
About this study
Official title: Gabapentin Vs. Lorazepam in Alcohol Withdrawal
The purpose of this study was to evaluate if the medication Gabapentin, which is not approved for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal syndrome compared to treatment with Lorazepam.
Read the detailed description
In the current protocol we evaluated a newer generation anticonvulsant agent, gabapentin. Gabapentin does not significantly interact with alcohol or other medications, has no abuse potential, and is excreted by the kidneys and not the liver .
The primary aim of the present application was to evaluate the efficacy of gabapentin in comparison to lorazepam (as a benzodiazepine gold standard) for the acute outpatient treatment of alcohol withdrawal (AW). In addition, evaluation of the lorazepam "rebound" effects observed during the current funding period will be replicated and compared with the response to gabapentin. Also, the acoustic startle response was used to evaluate the neurobiological effects of the medications on underlying AW-related CNS excitation, both during and immediately after AW. In addition, the effect of a history of multiple detoxifications on parameters such as withdrawal symptoms, CNS excitability, relapse to alcohol use, craving for alcohol, and response to medication treatment was explored.
- Conditions
- Alcohol Withdrawal Syndrome(AWS)
- Being tested
- Gabapentin, Lorazepam
- Keywords
- Alcohol Withdrawal Syndrome, CIWA-Ar, Acoustic Startle Procedure, Rebound Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
LorazepamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
Timeline Followback (TLFB) of drinking behaviors.
Secondary outcomes (4)
Lower startle reflex magnitudes as an index of CNS excitability or arousal.
Lower anxiety (Zung Anxiety Scale) and depression (Beck Depression.
Inventory) scores.
Subjective reports of sleep quality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startJul 2001
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Withdrawal Syndrome(AWS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert J. Malcolm, MD, Principal investigator, Medical University of South CarolinaCarrie Randall, PhD, Study director, Medical University of South Carolina, Center for Drug and Alcohol Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229125
- Sponsor's protocol ID
- NIAAAMAL10761-b
- Other IDs
- NIH P-50-AA010761
- Status last verified
- Sep 2005
- First submitted
- 27 Sep 2005
- Last updated
- 29 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin Vs. Lorazepam in Alcohol Withdrawal
- ClinicalTrials.gov ID
- NCT00229125
- Acronym / sponsor ID
- NIAAAMAL10761-b
- Conditions
- Alcohol Withdrawal Syndrome(AWS)
- Keywords
- Alcohol Withdrawal Syndrome, CIWA-Ar, Acoustic Startle Procedure, Rebound Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Jul 2001
- Study completion
- Sep 2005
- First posted
- 29 Sep 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.
The purpose of this study was to evaluate if the medication Gabapentin, which is not approved for the treatment of alcohol withdrawal, is effective in the treatment of alcohol withdrawal syndrome compared to treatment with Lorazepam.
Detailed description
In the current protocol we evaluated a newer generation anticonvulsant agent, gabapentin. Gabapentin does not significantly interact with alcohol or other medications, has no abuse potential, and is excreted by the kidneys and not the liver .
The primary aim of the present application was to evaluate the efficacy of gabapentin in comparison to lorazepam (as a benzodiazepine gold standard) for the acute outpatient treatment of alcohol withdrawal (AW). In addition, evaluation of the lorazepam "rebound" effects observed during the current funding period will be replicated and compared with the response to gabapentin. Also, the acoustic startle response was used to evaluate the neurobiological effects of the medications on underlying AW-related CNS excitation, both during and immediately after AW. In addition, the effect of a history of multiple detoxifications on parameters such as withdrawal symptoms, CNS excitability, relapse to alcohol use, craving for alcohol, and response to medication treatment was explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must be between 21-70 years of age (both genders will be recruited).
- Subjects must meet DSM-IV criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
- Subjects must have a mini-mental state score above 26.
- Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
- Subjects must have a minimum score on the Clinical Institute Withdrawal - - Assessment for Alcohol-Revised (CIWA-Ar) of 10 within 24 hours of initial assessment.
Key exclusion criteria (10 listed)
- Subjects with current (past month) DSM-IV diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine, caffeine, cannabis and cocaine dependence).
- Use of pharmacological agents within a five half-life period that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome (e.g.,tricyclic antidepressants, anticonvulsants, neuroleptics, benzodiazepines, some centrally-acting antihypertensives such as beta-blockers, alpha-adrenergic agonists, and calcium channel antagonists, wellbutrin, buspar, any sedative-hypnotics and opiates).
- Subjects with a history of idiopathic epilepsy.
- Subjects with diagnosis of schizophrenia, bipolar disorder or dementia.
- Subjects with liver function tests (AST or ALT) 4 times higher than normal. Serum levels will be drawn upon admission to study and study medications terminated if necessary.
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 |
|---|---|---|
| Gabapentin | Drug | – |
| Lorazepam | Drug | – |
Primary outcome
Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
Timeline Followback (TLFB) of drinking behaviors.
4 secondary outcomes
Lower startle reflex magnitudes as an index of CNS excitability or arousal.
Lower anxiety (Zung Anxiety Scale) and depression (Beck Depression.
Inventory) scores.
Subjective reports of sleep quality.
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 29 Sep 2005.
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.
Robert J. Malcolm, MD principal investigator
Medical University of South Carolina
Carrie Randall, PhD study director
Medical University of South Carolina, Center for Drug and Alcohol Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin and Lorazepam in people with Alcohol Withdrawal Syndrome(AWS), run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 10 inclusion and 10 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 29 Sep 2005. 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 phase mean?
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 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?
Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).. The study lists 2 primary outcomes in all. 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 29 Sep 2005.