AlcoholismPhase 4NCT00325182
The Effects of Levetiracetam on Alcohol Dependent Subjects
A Phase 4 study testing Levetiracetam in people with Alcoholism, run by Boston University at 1 site in United States.
Trial summary
This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with alcohol dependence cut down on their alcohol consumption. In addition, the investigation will assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Oct 2009
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM IV TR Diagnosis of Alcohol Dependence
- Male or female age 21-60 years old
- Able to provide informed consent and comprehend study procedures
- Negative urine toxicological screen for narcotics, amphetamines, sedative hypnotics and cannabinoids. The test may be repeated within a week.
- Score of > 8 on Alcohol Use Disorder Identification Test during screening
- Must be suitable for outpatient management
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- Express desire to stop drinking or reduce alcohol consumption with possible long-term goal of abstinence.
- Provide contact information for themselves or an alternate contact that the study staff will contact in case of missed appointment.
- Female subjects must be postmenopausal for at least one year, or practicing an effective method of birth control before entry and throughout the study
- Must be able to take oral medications, adhere to regimen and be willing to return for follow up visits
- Must have breath alcohol concentration of no more than 0.025% when signing the informed consent
Who cannot join
- Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine or caffeine
- DSM IV- TR diagnosis of any current Axis I diagnosis other than alcohol, nicotine or caffeine dependence that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy that might interfere with the course of the study
- Receiving inpatient or outpatient treatment for alcohol dependence (with the exception of AA or other self-help groups) within the 4 weeks prior to enrollment
- Subjects with a score of 10 or greater on the CIWA-Ar at visits one and two
- Currently being treated with disulfiram or naltrexone
- Currently being treated with any the following medications: a) Antipsychotic agent [b) Lithium Carbonate c) Anticonvulsant agent d) Hypnotics e) Antianxiety Agents f) Chronic opiate treatment with methadone, laam, buprenorphine; oxycodone, morphine, etc g) Stimulant treatment
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- Subjects who are legally mandated to participate in alcohol treatment program
- Subjects who have had a suicide attempt or suicidal ideation within 30 days of the first visit
- Subjects with renal disease
- Subjects with AST and ALT >3 times the upper limit of the normal range during screening. Test may be repeated prior to enrollment. If repeat lab values are all within acceptable ranges subject may continue study participation.
- Major neurological disorder including seizures
- Subjects who are pregnant or lactating
- Subjects known to have clinically significant medical conditions, including, but not limited to: symptomatic CAD or PVD, malignancy or history of malignancy in the last 5 years, pulmonary disorders, endocrinological disorders
- Subjects with prior hypersensitivity to Keppra
- Subjects with history of medically complicated withdrawal from alcohol.
- Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings and contraindications outlined in the Keppra package insert
- Subjects with cardiac pacemaker or metal surgical implant
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Dept of Psychiatry Clinical Studies Unit
Boston, Massachusetts, 02118
About this study
This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with alcohol dependence cut down on their alcohol consumption. In addition, the investigation will assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation. Matched group of historical controls of alcohol dependent patients receiving placebo will be used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.
Read the detailed description
Alcoholism is a chronic disease with numerous psychological, social and medical consequences. Alcohol use disorders are one of the most prevalent psychiatric disorders in general population in the US. Alcoholism not only disrupts an individual's life, health and ability to function in the society, has tremendous impact on families and communities, but also is associated with enormous economic cost for society. The medical and social impact of alcoholism can be reduced via effective treatments. Although medical, psychological and social approaches have demonstrated some efficacy, no specific method has consistently shown superiority. Similarly, currently available pharmacological treatments for alcohol use disorders are associated with moderate efficacy, indicating that further efforts are required to develop novel interventions.
The rewarding effects of alcohol are at least partially mediated via dopamine pathways that originate in the ventral tegmental area and project to the nucleus accumbens. Alcohol through its effects on GABA receptor activity decreases the inhibitory effect of GABA on the dopaminergic neurons in ventral tegmental area and therefore facilitates dopamine neurotransmission. Medications that modulate excitatory neurotransmission in the brain (glutamate) and facilitate inhibitory effects of GABA have been shown to be clinically effective in treatment of alcoholism.
Keppra is a novel antiepileptic medication currently approved for treatment of partial onset seizures as an adjunctive agent. It has a unique mechanism of action in that it reduces negative allosteric effects of Zn++ and Beta- carboline in two main inhibitory receptors in the CNS- the GABA A and glycine receptors. These modulators inhibit the influx of chloride though both of these receptor complexes and are therefore considered excitatory mediators. Keppra prevents the negative modulation and promotes chloride flux, thereby, inhibiting neurotransmission.
Limited laboratory work with levetiracetam (Keppra) has shown that the medication can reverse the anxiogenic effect of benzodiazepine withdrawal in mice (Y. Lamberty et al., 2002). Furthermore, Keppra was investigated for its potential to prevent alcohol withdrawal symptoms in mice. In this study levetiracetam dose-dependently prevented spontaneous tremors and handling induced convulsions in alcohol dependent mice. (Y. Lamberty et al., 2002). Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.
- Conditions
- Alcoholism
- Being tested
- Levetiracetam, Historical controls
- Keywords
- Alcoholism
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Historical controlsOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Levetiracetam | Experimental | Levetiracetam dose schedule Days 1-4 250 mg bid Days 5- 19 500 mg bid Days 20 -70 1000 mg bid Days 71-78 500 mg bid Days 79-85 250 mg bid Days 86-91 Receives: Drug: Levetiracetam |
| Historical controls | Placebo comparator | Historical controls from COMBINE study who receive a placebo Receives: Other: Historical controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean number of drinks
The primary outcome of this study will be determined by comparing the mean drinks consumed per day at baseline (the month prior to the screening session) compared with the mean drinks per day consumed during week 11 of the treatment period.
Measured: Baseline and at 11 weeks
Secondary outcomes (2)
Heavy drinks per drinking day
Mean heavy drinks per drinking day, OCDS scores, MOS-Sleep Scores, and POMS scores.
Measured: At 13 weeks and last value carries forward approaches
OCDS scores, MOS-Sleep Scores, and POMS scores.
Mean OCDS scores, MOS-Sleep Scores, and POMS scores.
Measured: At 13 weeks and last value carries forward approaches
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Ofra Sarid-Segal, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325182
- Sponsor's protocol ID
- H-23008
- Status last verified
- Apr 2007
- First submitted
- 11 May 2006
- Last updated
- 15 Mar 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Levetiracetam on Alcohol Dependent Subjects
- ClinicalTrials.gov ID
- NCT00325182
- Acronym / sponsor ID
- H-23008
- Conditions
- Alcoholism
- Keywords
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Jan 2006 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 May 2006 (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.
This study will attempt to examine whether Levetiracetam (Keppra (TM)) can help people with alcohol dependence cut down on their alcohol consumption. In addition, the investigation will assess the effectiveness of Keppra on reducing withdrawal symptoms post alcohol cessation. Matched group of historical controls of alcohol dependent patients receiving placebo will be used for comparison.Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.
Detailed description
Alcoholism is a chronic disease with numerous psychological, social and medical consequences. Alcohol use disorders are one of the most prevalent psychiatric disorders in general population in the US. Alcoholism not only disrupts an individual's life, health and ability to function in the society, has tremendous impact on families and communities, but also is associated with enormous economic cost for society. The medical and social impact of alcoholism can be reduced via effective treatments. Although medical, psychological and social approaches have demonstrated some efficacy, no specific method has consistently shown superiority. Similarly, currently available pharmacological treatments for alcohol use disorders are associated with moderate efficacy, indicating that further efforts are required to develop novel interventions.
The rewarding effects of alcohol are at least partially mediated via dopamine pathways that originate in the ventral tegmental area and project to the nucleus accumbens. Alcohol through its effects on GABA receptor activity decreases the inhibitory effect of GABA on the dopaminergic neurons in ventral tegmental area and therefore facilitates dopamine neurotransmission. Medications that modulate excitatory neurotransmission in the brain (glutamate) and facilitate inhibitory effects of GABA have been shown to be clinically effective in treatment of alcoholism.
Keppra is a novel antiepileptic medication currently approved for treatment of partial onset seizures as an adjunctive agent. It has a unique mechanism of action in that it reduces negative allosteric effects of Zn++ and Beta- carboline in two main inhibitory receptors in the CNS- the GABA A and glycine receptors. These modulators inhibit the influx of chloride though both of these receptor complexes and are therefore considered excitatory mediators. Keppra prevents the negative modulation and promotes chloride flux, thereby, inhibiting neurotransmission.
Limited laboratory work with levetiracetam (Keppra) has shown that the medication can reverse the anxiogenic effect of benzodiazepine withdrawal in mice (Y. Lamberty et al., 2002). Furthermore, Keppra was investigated for its potential to prevent alcohol withdrawal symptoms in mice. In this study levetiracetam dose-dependently prevented spontaneous tremors and handling induced convulsions in alcohol dependent mice. (Y. Lamberty et al., 2002). Based on the mechanism of action of Keppra we hypothesize that it may be effective in promoting abstinence and reducing drinking behavior in alcohol dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Levetiracetam | Experimental | Drug: LevetiracetamLevetiracetam dose schedule Days 1-4 250 mg bid Days 5- 19 500 mg bid Days 20 -70 1000 mg bid Days 71-78 500 mg bid Days 79-85 250 mg bid Days 86-91 |
| Historical controls | Placebo comparator | Other: Historical controlsHistorical controls from COMBINE study who receive a placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- DSM IV TR Diagnosis of Alcohol Dependence
- Male or female age 21-60 years old
- Able to provide informed consent and comprehend study procedures
- Negative urine toxicological screen for narcotics, amphetamines, sedative hypnotics and cannabinoids. The test may be repeated within a week.
- Score of > 8 on Alcohol Use Disorder Identification Test during screening
Key exclusion criteria (17 listed)
- Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine or caffeine
- DSM IV- TR diagnosis of any current Axis I diagnosis other than alcohol, nicotine or caffeine dependence that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy that might interfere with the course of the study
- Receiving inpatient or outpatient treatment for alcohol dependence (with the exception of AA or other self-help groups) within the 4 weeks prior to enrollment
- Subjects with a score of 10 or greater on the CIWA-Ar at visits one and two
- Currently being treated with disulfiram or naltrexone
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 |
|---|---|---|
| LevetiracetamAlso: Keppra | Drug | Intervention: Levetiracetam |
| Historical controls | Other | Historical controls |
Primary outcome
Change in mean number of drinks
Time frame: Baseline and at 11 weeks
The primary outcome of this study will be determined by comparing the mean drinks consumed per day at baseline (the month prior to the screening session) compared with the mean drinks per day consumed during week 11 of the treatment period.
2 secondary outcomes
Heavy drinks per drinking day
Time frame: At 13 weeks and last value carries forward approaches
OCDS scores, MOS-Sleep Scores, and POMS scores.
Time frame: At 13 weeks and last value carries forward approaches
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 15 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Ofra Sarid-Segal, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levetiracetam in people with Alcoholism, run by Boston University 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 11 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: finished, as of the sponsor's last update on 15 Mar 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in mean number of drinks (time frame: Baseline and at 11 weeks). 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 15 Mar 2017.