AlcoholismPhase 2NCT00141115
Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
A Phase 2 study testing levetiracetam in people with Alcoholism and Generalized Anxiety Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism, Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence and a comorbid anxiety disorder, including: panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, no otherwise specified (NOS).
- Individuals capable of giving informed consent and capable of complying with study procedures.
- Individuals must have clinically significant anxiety.
- Individuals must have current average alcohol use over past 28 days with > 4 drinking days per week and >4 standard drinks/drinking day for women and > 5 standard drinks/drinking day for men.
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy test done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant the study medication will be discontinued.
- Individual's breathalyzer reading at the time of signing consent must be < 0.04%.
Who cannot join
- Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-Text Revision (DSM-IV-TR) supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition (SCID-I/P) that in the investigator's judgment might require pharmacological intervention, with the exceptions of alcohol dependence and a comorbid anxiety disorder (panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, NOS). Current diagnoses of post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder are exclusionary.
- Individuals with evidence of moderate to severe alcohol withdrawal that would require pharmacologic intervention.
- Individuals meeting DSM IV criteria for current cocaine or opioid dependence.
- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension and tachycardia (systolic blood pressure [SBP] > 150 mm Hg, diastolic blood pressure [DBP] > 90 mm Hg, or a sitting quietly heart rate [HR] > 100 bpm), acute hepatitis (patients with chronic mildly elevated transaminase levels ((2-3 x upper limit of normal) are acceptable) or poorly controlled diabetes.
- Patients currently taking prescribed psychotropic medications.
- Patients with a known sensitivity to levetiracetam.
Show all 10Show fewer
- Individuals who have exhibited suicidal or homicidal behavior within the past two years or have current active suicidal ideation.
- Women who are pregnant or nursing.
- Individuals physiologically dependent on any other drugs (excluding nicotine, caffeine).
- Individuals with a history of a hazardous drinking behavior (e.g., driving while intoxicated convictions, violent crimes committed while intoxicated) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety
The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.
Read the detailed description
Alcohol dependence is frequently associated with anxiety disorders. Treatment studies of individuals suffering from both alcohol dependence and anxiety have been limited. Anti-seizure medications have been used for the treatment of alcohol withdrawal for three decades. More recently, anti-seizure medications have been shown to reduce drinking and promote abstinence, and reduce drinking in abstinent alcoholics. Levetiracetam is a newer anti-seizure medication, with a structure different than that of other anti-seizure medications, that is safe and generally well tolerated. The Food and Drug Administration (FDA) has approved levetiracetam for use with other anti-seizure medications in the treatment of epilepsy in adults. The metabolism of levetiracetam is less complicated than older anti-seizure medications, which makes it easier to use and better tolerated, and it is not likely to interact with other medicines. Levetiracetam has been shown to prevent anxiety during sedative withdrawal, which is similar to alcohol withdrawal, in a laboratory study using mice. Levetiracetam also had anti-anxiety effects in laboratory study using mice. Given that other anti-seizure medications have been shown to be helpful in treating alcohol dependence, that levetiracetam is not likely to have interactions with other medications, and that in animals levetiracetam appeared to be helpful for treating a condition similar to alcohol dependence and anxiety, we believe it should be studied for the treatment of alcohol dependent patients with anxiety disorders.
- Conditions
- Alcoholism, Generalized Anxiety Disorder, Panic Disorder, Social Phobia, Anxiety Disorders
- Being tested
- levetiracetam
- Keywords
- Substance-induced anxiety disorder
- Medical subject headings
- Alcoholism, Generalized Anxiety Disorder, Panic Disorder, Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Also called keppra
Levetiracetam 1500 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Levetiracetam 1500 mg BID Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Reported Reductions in Alcohol Consumption
Number of participants who reduced drinking during the trial
Measured: over 9 weeks of study or length of participation
Secondary outcomes (1)
Percent of Drinking Days
daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back
Measured: assessed daily, reported for baseline 28 days compared to last 28 days of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlcoholismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, John Mariani MD, New York State Psychiatric Institute
- Investigators
- Frances R Levin, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141115
- Sponsor's protocol ID
- 4773
- Status last verified
- Apr 2019
- First submitted
- 31 Aug 2005
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety
- ClinicalTrials.gov ID
- NCT00141115
- Acronym / sponsor ID
- 4773
- Conditions
- Alcoholism, Generalized Anxiety Disorder, Panic Disorder, Social Phobia, Anxiety Disorders
- Keywords
- Substance-induced anxiety disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 15 Sep 2017
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 determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.
Detailed description
Alcohol dependence is frequently associated with anxiety disorders. Treatment studies of individuals suffering from both alcohol dependence and anxiety have been limited. Anti-seizure medications have been used for the treatment of alcohol withdrawal for three decades. More recently, anti-seizure medications have been shown to reduce drinking and promote abstinence, and reduce drinking in abstinent alcoholics. Levetiracetam is a newer anti-seizure medication, with a structure different than that of other anti-seizure medications, that is safe and generally well tolerated. The Food and Drug Administration (FDA) has approved levetiracetam for use with other anti-seizure medications in the treatment of epilepsy in adults. The metabolism of levetiracetam is less complicated than older anti-seizure medications, which makes it easier to use and better tolerated, and it is not likely to interact with other medicines. Levetiracetam has been shown to prevent anxiety during sedative withdrawal, which is similar to alcohol withdrawal, in a laboratory study using mice. Levetiracetam also had anti-anxiety effects in laboratory study using mice. Given that other anti-seizure medications have been shown to be helpful in treating alcohol dependence, that levetiracetam is not likely to have interactions with other medications, and that in animals levetiracetam appeared to be helpful for treating a condition similar to alcohol dependence and anxiety, we believe it should be studied for the treatment of alcohol dependent patients with anxiety disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: levetiracetamLevetiracetam 1500 mg BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence and a comorbid anxiety disorder, including: panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, no otherwise specified (NOS).
- Individuals capable of giving informed consent and capable of complying with study procedures.
- Individuals must have clinically significant anxiety.
- Individuals must have current average alcohol use over past 28 days with > 4 drinking days per week and >4 standard drinks/drinking day for women and > 5 standard drinks/drinking day for men.
- Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy test done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant the study medication will be discontinued.
Key exclusion criteria (10 listed)
- Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-Text Revision (DSM-IV-TR) supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition (SCID-I/P) that in the investigator's judgment might require pharmacological intervention, with the exceptions of alcohol dependence and a comorbid anxiety disorder (panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, NOS). Current diagnoses of post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder are exclusionary.
- Individuals with evidence of moderate to severe alcohol withdrawal that would require pharmacologic intervention.
- Individuals meeting DSM IV criteria for current cocaine or opioid dependence.
- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension and tachycardia (systolic blood pressure [SBP] > 150 mm Hg, diastolic blood pressure [DBP] > 90 mm Hg, or a sitting quietly heart rate [HR] > 100 bpm), acute hepatitis (patients with chronic mildly elevated transaminase levels ((2-3 x upper limit of normal) are acceptable) or poorly controlled diabetes.
- Patients currently taking prescribed psychotropic medications.
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: keppraLevetiracetam 1500 mg BID | Drug | Levetiracetam |
Primary outcome
Participants Who Reported Reductions in Alcohol Consumption
Time frame: over 9 weeks of study or length of participation
Number of participants who reduced drinking during the trial
1 secondary outcome
Percent of Drinking Days
Time frame: assessed daily, reported for baseline 28 days compared to last 28 days of study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- STARS clinic websiteLink provided by the sponsor.
Related trials for Alcoholism
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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.
Frances R Levin, MD principal investigator
New York State Psychiatric Institute
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 levetiracetam in people with Alcoholism and Generalized Anxiety Disorder, run by New York State Psychiatric Institute 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 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 24 Apr 2019. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants Who Reported Reductions in Alcohol Consumption (time frame: over 9 weeks of study or length of participation). 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 24 Apr 2019.