Alcohol AbuseNCT01168687

Effects of Levetiracetam (Keppra) on Alcohol Consumption

A study testing Levetiracetam (Keppra) in people with Alcohol Abuse and Drug Abuse, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Abuse, Drug Abuse
What is being tested?: Levetiracetam (Keppra)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Nov 2010
Phase: Interventional
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 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults who are social drinkers 21 and 50 years of age.
Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
Body Mass Index (BMI)>18 and <30.
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]).
Able and willing to provide written informed consent.
Able to understand and follow the instructions of the investigator, and understand all rating scales.
Have a negative urine drug screen at all visits, with the exception of cannabinoids.

Who cannot join

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.
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.
Lifetime use of PCP or ketamine greater than 10 times, or at any time in the last 24 months.
History of abusing inhalants (such as glue, toluene or other volatile substances).
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.
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.

Show all 25Show fewer

Binge drinking more than three times per week (binge defined as >5 standard drinks in one session).
Alcohol consumption >21 drinks/week for women and >25 drinks/week for men.
Currently trying to quit alcohol and/or recreational drug use.
Positive for lifetime abnormal opioid use or prescription drug abuse.
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.
Bilirubin more than 2 times the normal upper limit.
AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 times the normal upper limit.
Body Mass Index >30 or <18
Pregnancy or a woman of child bearing potential not currently using an adequate means of contraception.
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).
BAC level greater than 0.02% at the beginning of visits 1, 7, or 8 (within margin of error for detection).
Estimated creatinine clearance < 50 ml/min.
Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of outcome measures as defined above.
Allergy to levetiracetam.
Significant cardiac pathology or abnormal initial EKG with QT/QTc interval prolongation > 480 m secs at baseline.
Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
Subjects who are unable to read or speak English.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital Oakland Research Institute- CRC
Berkeley, California, 94705

Other trials in United States

About this study

Official title: Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake

Read the 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:

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.
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.
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.

Conditions: Alcohol Abuse, Drug Abuse
Being tested: Levetiracetam (Keppra), Placebo
Keywords: keppra, levetiracetam, alcoholism, genetics, subjective report
Medical subject headings: Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levetiracetam (Keppra)Drug
Also called Keppra
Group A: Twenty moderate to heavy social alcohol users 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 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.
PlaceboDrug

Study groups in NCT01168687
Study group	Role	What they receive
Group A	Experimental	Twenty moderate to heavy social alcohol users 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. Receives: Drug: Levetiracetam (Keppra); Drug: Placebo
Group B	Experimental	Twenty moderate to heavy social alcohol users 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. Receives: Drug: Levetiracetam (Keppra); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Standard Alcoholic Drinks Per Treatment 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.
Measured: During each 14 day treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Nov 2010

First posted23 Jul 2010 (estimated)
Study startNov 2008
Primary completionNov 2009
Study completionNov 2010

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.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Alcohol AbuseStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01168687
Sponsor's protocol ID: H1815-29512-02
Other IDs: W81XWH-05-1-0215
Status last verified: Aug 2020
First submitted: 6 Oct 2008
Last updated: 28 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Angehagen M, Margineanu DG, Ben-Menachem E, Ronnback 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. doi: 10.1097/00001756-200303030-00035.
PubMed 12634506
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. doi: 10.1016/s0014-2999(03)01933-2.
PubMed 12877934
Brockmoller 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. doi: 10.1016/j.clpt.2005.02.003.
PubMed 15961984
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. doi: 10.1124/jpet.104.079327. Epub 2005 Jan 11.
PubMed 15644427
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. doi: 10.1126/science.1123654. Epub 2006 Mar 16.
PubMed 16543415
Grunewald R. Levetiracetam in the treatment of idiopathic generalized epilepsies. Epilepsia. 2005;46 Suppl 9:154-60. doi: 10.1111/j.1528-1167.2005.00329.x.
PubMed 16302890
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. doi: 10.1006/mcne.2001.1013.
PubMed 11520183
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. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available.
PubMed 16702910
LaMotte RH, Lundberg LE, Torebjork HE. Pain, hyperalgesia and activity in nociceptive C units in humans after intradermal injection of capsaicin. J Physiol. 1992 Mar;448:749-64. doi: 10.1113/jphysiol.1992.sp019068.
PubMed 1593488
Lipscomb TR, Carpenter JA, Nathan PE. Static ataxia: a predictor of alcoholism? Br J Addict Alcohol Other Drugs. 1979 Sep;74(3):289-94. doi: 10.1111/j.1360-0443.1979.tb01350.x. No abstract available.
PubMed 290377
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. doi: 10.1001/archpsyc.1980.01780180085010.
PubMed 7377914
Lukyanetz EA, Shkryl VM, Kostyuk PG. Selective blockade of N-type calcium channels by levetiracetam. Epilepsia. 2002 Jan;43(1):9-18. doi: 10.1046/j.1528-1157.2002.24501.x.
PubMed 11879381
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. doi: 10.1073/pnas.0308208101. Epub 2004 Jun 21.
PubMed 15210974
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. doi: 10.1016/s0028-3908(03)00248-x.
PubMed 12941379
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. doi: 10.1523/JNEUROSCI.3446-04.2004.
PubMed 15525770

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-Controlled Crossover Trial of Levetiracetam on Ethanol Intake
ClinicalTrials.gov ID: NCT01168687
Acronym / sponsor ID: H1815-29512-02
Conditions: Alcohol Abuse, Drug Abuse
Keywords: keppra, levetiracetam, alcoholism, genetics, subjective report
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: United States Department of Defense, University of California
Study start: Nov 2008
Primary completion: Nov 2009 (actual)
Study completion: Nov 2010 (actual)
First posted: 23 Jul 2010 (estimated)
Results: Posted 25 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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.
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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Levetiracetam (Keppra), Drug: PlaceboTwenty moderate to heavy social alcohol users 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	Experimental	Drug: Levetiracetam (Keppra), Drug: PlaceboTwenty moderate to heavy social alcohol users 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.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy adults who are social drinkers 21 and 50 years of age.
Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
Body Mass Index (BMI)>18 and <30.
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]).
Able and willing to provide written informed consent.

Key exclusion criteria (25 listed)

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.
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.
Lifetime use of PCP or ketamine greater than 10 times, or at any time in the last 24 months.
History of abusing inhalants (such as glue, toluene or other volatile substances).
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.

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
Levetiracetam (Keppra)Also: KeppraGroup A: Twenty moderate to heavy social alcohol users 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 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	Group A, Group B
Placebo	Drug	Group A, Group B

Primary outcome

Standard Alcoholic Drinks Per Treatment Period
Time frame: During each 14 day treatment 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.

Results and safety

Results posted to the registry on 25 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Crossover Between Low Dose Keppra and Placebo	23	23
Group B: Crossover Between High Dose Keppra and Placebo	23	23

Primary outcome: Standard Alcoholic Drinks Per Treatment Period

Time frame: During each 14 day treatment period. Mean (Standard Error). Unit: number of drinks per treatment period

Measure	All Subjects (n = 46) Placebo n = 46	All Subjects (n = 46) Levetiracetam n = 46
Value	41.2 (2.8)	45.4 (3.6)

Population analysed: All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects (n = 46) Placebo	0 of 46 (0%)	0 of 46 (0%)	Not reported
All Subjects (n = 46) Levetiracetam	0 of 46 (0%)	0 of 46 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12634506Angehagen M, Margineanu DG, Ben-Menachem E, Ronnback 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. doi: 10.1097/00001756-200303030-00035.
Background: PubMed 12877934Ardid 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. doi: 10.1016/s0014-2999(03)01933-2.
Background: PubMed 15961984Brockmoller 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. doi: 10.1016/j.clpt.2005.02.003.
Background: PubMed 15644427Cataldi 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. doi: 10.1124/jpet.104.079327. Epub 2005 Jan 11.
Background: PubMed 16543415Dong 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. doi: 10.1126/science.1123654. Epub 2006 Mar 16.
Background: PubMed 16302890Grunewald R. Levetiracetam in the treatment of idiopathic generalized epilepsies. Epilepsia. 2005;46 Suppl 9:154-60. doi: 10.1111/j.1528-1167.2005.00329.x.
Background: PubMed 11520183Kim 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. doi: 10.1006/mcne.2001.1013.
Background: PubMed 16702910Krebs 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. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available.
Background: PubMed 1593488LaMotte RH, Lundberg LE, Torebjork HE. Pain, hyperalgesia and activity in nociceptive C units in humans after intradermal injection of capsaicin. J Physiol. 1992 Mar;448:749-64. doi: 10.1113/jphysiol.1992.sp019068.
Background: PubMed 290377Lipscomb TR, Carpenter JA, Nathan PE. Static ataxia: a predictor of alcoholism? Br J Addict Alcohol Other Drugs. 1979 Sep;74(3):289-94. doi: 10.1111/j.1360-0443.1979.tb01350.x. No abstract available.
Background: PubMed 7377914Lipscomb 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. doi: 10.1001/archpsyc.1980.01780180085010.
Background: PubMed 11879381Lukyanetz EA, Shkryl VM, Kostyuk PG. Selective blockade of N-type calcium channels by levetiracetam. Epilepsia. 2002 Jan;43(1):9-18. doi: 10.1046/j.1528-1157.2002.24501.x.

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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.

Robert O. Messing, M.D. principal investigator

UCSF; Department of Neurology; Ernest Gallo Clinic and Research Center

Jennifer M. Mitchell, Ph.D. principal investigator

UCSF; Department of Neurology; Ernest Gallo Clinic and Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Levetiracetam (Keppra) in people with Alcohol Abuse and Drug Abuse, run by University of California, San Francisco 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 7 inclusion and 25 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 28 Aug 2020. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2013). 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?

Standard Alcoholic Drinks Per Treatment Period (time frame: During each 14 day treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01168687, which also lists 22 linked publications.

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 28 Aug 2020.