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Effects of Levetiracetam (Keppra) on Alcohol Consumption

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168687
First Posted: July 23, 2010
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Department of Defense
University of California
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.

Condition Intervention
Alcohol Abuse Drug Abuse Drug: Levetiracetam (Keppra) Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Standard Alcoholic Drinks Per Treatment Period [ Time Frame: This will be assessed during a 42-day period. ]
    The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.


Enrollment: 46
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.
Drug: Levetiracetam (Keppra)

Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.

Group B: Twenty moderate to heavy social alcohol users as described above will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.

Other Name: Keppra
Drug: Placebo
Experimental: Group B
Twenty moderate to heavy social alcohol users as described above will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Drug: Levetiracetam (Keppra)

Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.

Group B: Twenty moderate to heavy social alcohol users as described above will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.

Other Name: Keppra
Drug: Placebo

Detailed Description:

The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users who are social drinkers.

The specific aims are to:

  1. Determine if levetiracetam alters daily alcohol consumption by comparing the mean drinks consumed per day during levetiracetam administration compared with the mean drinks per day consumed during placebo administration.
  2. Obtain blood that will be banked for future genetic analysis of polymorphisms in genes that may predict the level of response to alcohol or effects of levetiracetam on alcohol consumption.
  3. Test whether the AccuswayTM platform can detect changes in body sway in light to moderate or heavy social drinkers and in subjects taking levetiracetam versus placebo.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults who are social drinkers 21 and 50 years of age.
  2. Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
  3. Body Mass Index (BMI)>18 and <30.
  4. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]).
  5. Able and willing to provide written informed consent.
  6. Able to understand and follow the instructions of the investigator, and understand all rating scales.
  7. Have a negative urine drug screen at all visits, with the exception of cannabinoids.

Exclusion Criteria:

  1. Positive urine drug screen, except cannabinoids. Occasional cannabinoid use is allowed, however daily use, dependence, or if considered more than a casual user by study physician, subject will be excluded.
  2. Use of cocaine, amphetamines or other stimulants, hallucinogens, ecstasy or other psychoactive drugs, greater than 10 times in the last 24 months or at anytime in the past 60 days.
  3. Lifetime use of PCP or ketamine greater than 10 times, or at any time in the last 24 months.
  4. History of abusing inhalants (such as glue, toluene or other volatile substances).
  5. Current or past dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol, as determined by the study physician's assessment.
  6. Current or prior enrollment in an alcohol or other drug treatment program, or current legal problems relating to alcohol or other drug use, including awaiting trial or supervision by a parole or probation officer.
  7. Binge drinking more than three times per week (binge defined as >5 standard drinks in one session).
  8. Alcohol consumption >21 drinks/week for women and >25 drinks/week for men.
  9. Currently trying to quit alcohol and/or recreational drug use.
  10. Positive for lifetime abnormal opioid use or prescription drug abuse.
  11. Clinically significant medical or psychiatric illness (including anxiety or panic disorders) as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
  12. Bilirubin more than 2 times the normal upper limit.
  13. AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 times the normal upper limit.
  14. Body Mass Index >30 or <18
  15. Pregnancy or a woman of child bearing potential not currently using an adequate means of contraception.
  16. Currently taking any medication other than over-the-counter nonsteroidal anti-inflammatories, acetaminophen, inhaled asthma therapy, contraceptives, nicotine patches, and over-the-counter non-sedating antihistamines.NSAIDs, acetaminophen, or any other OTC (including herbal) medication (unless cleared by study physician).
  17. BAC level greater than 0.02% at the beginning of visits 1, 7, or 8 (within margin of error for detection).
  18. Estimated creatinine clearance < 50 ml/min.
  19. Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
  20. Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
  21. Allergy to levetiracetam.
  22. Significant cardiac pathology or abnormal initial EKG with QT/QTc interval prolongation > 480 m secs at baseline.
  23. Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
  24. Subjects who are unable to read or speak English.
  25. Those, in the opinion of the investigator, who are considered unable to adhere to scheduled appointments, unlikely to comply with the study protocol, or who are unsuitable for any other reason.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168687


Locations
United States, California
Children's Hospital Oakland Research Institute- CRC
Berkeley, California, United States, 94705
Sponsors and Collaborators
University of California, San Francisco
United States Department of Defense
University of California
Investigators
Principal Investigator: Robert O. Messing, M.D. UCSF; Department of Neurology; Ernest Gallo Clinic and Research Center
Principal Investigator: Jennifer M. Mitchell, Ph.D. UCSF; Department of Neurology; Ernest Gallo Clinic and Research Center
  More Information

Publications:
Hatakeyama S, Wakamori M, Ino M, Miyamoto N, Takahashi E, Yoshinaga T, Sawada K, Imoto K, Tanaka I, Yoshizawa T, Nishizawa Y, Mori Y, Niidome T, Shoji S. Differential nociceptive responses in mice lacking the alpha(1B) subunit of N-type Ca(2+) channels. Neuroreport. 2001 Aug 8;12(11):2423-7.
Angehagen M, Margineanu DG, Ben-Menachem E, Rönnbäck L, Hansson E, Klitgaard H. Levetiracetam reduces caffeine-induced Ca2+ transients and epileptiform potentials in hippocampal neurons. Neuroreport. 2003 Mar 3;14(3):471-5.
Ardid D, Lamberty Y, Alloui A, Coudore-Civiale MA, Klitgaard H, Eschalier A. Antihyperalgesic effect of levetiracetam in neuropathic pain models in rats. Eur J Pharmacol. 2003 Jul 18;473(1):27-33.
Brockmöller J, Thomsen T, Wittstock M, Coupez R, Lochs H, Roots I. Pharmacokinetics of levetiracetam in patients with moderate to severe liver cirrhosis (Child-Pugh classes A, B, and C): characterization by dynamic liver function tests. Clin Pharmacol Ther. 2005 Jun;77(6):529-41.
Cataldi M, Lariccia V, Secondo A, di Renzo G, Annunziato L. The antiepileptic drug levetiracetam decreases the inositol 1,4,5-trisphosphate-dependent [Ca2+]I increase induced by ATP and bradykinin in PC12 cells. J Pharmacol Exp Ther. 2005 May;313(2):720-30. Epub 2005 Jan 11.
Dong M, Yeh F, Tepp WH, Dean C, Johnson EA, Janz R, Chapman ER. SV2 is the protein receptor for botulinum neurotoxin A. Science. 2006 Apr 28;312(5773):592-6. Epub 2006 Mar 16.
Grünewald R. Levetiracetam in the treatment of idiopathic generalized epilepsies. Epilepsia. 2005;46 Suppl 9:154-60.
Kim C, Jun K, Lee T, Kim SS, McEnery MW, Chin H, Kim HL, Park JM, Kim DK, Jung SJ, Kim J, Shin HS. Altered nociceptive response in mice deficient in the alpha(1B) subunit of the voltage-dependent calcium channel. Mol Cell Neurosci. 2001 Aug;18(2):235-45.
Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9.
LaMotte RH, Lundberg LE, Torebjörk HE. Pain, hyperalgesia and activity in nociceptive C units in humans after intradermal injection of capsaicin. J Physiol. 1992 Mar;448:749-64.
Lipscomb TR, Carpenter JA, Nathan PE. Static ataxia: a predictor of alcoholism? Br J Addict Alcohol Other Drugs. 1979 Sep;74(3):289-94.
Lipscomb TR, Nathan PE. Blood alcohol level discrimination. The effects of family history of alcoholism, drinking pattern, and tolerance. Arch Gen Psychiatry. 1980 May;37(5):571-6.
Lukyanetz EA, Shkryl VM, Kostyuk PG. Selective blockade of N-type calcium channels by levetiracetam. Epilepsia. 2002 Jan;43(1):9-18.
Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh SM, Matagne A, Fuks B. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci U S A. 2004 Jun 29;101(26):9861-6. Epub 2004 Jun 21.
Madeja M, Margineanu DG, Gorji A, Siep E, Boerrigter P, Klitgaard H, Speckmann EJ. Reduction of voltage-operated potassium currents by levetiracetam: a novel antiepileptic mechanism of action? Neuropharmacology. 2003 Oct;45(5):661-71.
Newton PM, Orr CJ, Wallace MJ, Kim C, Shin HS, Messing RO. Deletion of N-type calcium channels alters ethanol reward and reduces ethanol consumption in mice. J Neurosci. 2004 Nov 3;24(44):9862-9.
Pisani A, Bonsi P, Martella G, De Persis C, Costa C, Pisani F, Bernardi G, Calabresi P. Intracellular calcium increase in epileptiform activity: modulation by levetiracetam and lamotrigine. Epilepsia. 2004 Jul;45(7):719-28.
Rigo JM, Hans G, Nguyen L, Rocher V, Belachew S, Malgrange B, Leprince P, Moonen G, Selak I, Matagne A, Klitgaard H. The anti-epileptic drug levetiracetam reverses the inhibition by negative allosteric modulators of neuronal GABA- and glycine-gated currents. Br J Pharmacol. 2002 Jul;136(5):659-72.
Rowbotham MC, Manville NS, Ren J. Pilot tolerability and effectiveness study of levetiracetam for postherpetic neuralgia. Neurology. 2003 Sep 23;61(6):866-7.
Schuckit MA, Smith TL, Kalmijn J. Findings across subgroups regarding the level of response to alcohol as a risk factor for alcohol use disorders: a college population of women and Latinos. Alcohol Clin Exp Res. 2004 Oct;28(10):1499-508.
Saegusa H, Kurihara T, Zong S, Kazuno A, Matsuda Y, Nonaka T, Han W, Toriyama H, Tanabe T. Suppression of inflammatory and neuropathic pain symptoms in mice lacking the N-type Ca2+ channel. EMBO J. 2001 May 15;20(10):2349-56.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01168687     History of Changes
Other Study ID Numbers: H1815-29512-02
W81XWH-05-1-0215 ( Other Grant/Funding Number: US Dept. of the Army )
First Submitted: October 6, 2008
First Posted: July 23, 2010
Results First Submitted: January 16, 2013
Results First Posted: February 25, 2013
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by University of California, San Francisco:
keppra
levetiracetam
alcoholism
genetics
subjective report

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Etiracetam
Piracetam
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents


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