AlcoholismPhase 2NCIG 002NCT00970814
Levetiracetam XR in Very Heavy Drinkers
A Phase 2 study testing BBCET, Levetiracetam XR and Sugar Pill in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 5 sites in United States.
Trial summary
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- BBCET, Levetiracetam XR and Sugar Pill
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2009to Oct 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must be at least 18 years of age.
- The subject must have a DSM-IV diagnosis of current alcohol dependence.
- The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
- The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:
- oral contraceptives
Show all 18Show fewer
- contraceptive sponge
- patch
- barrier (diaphragm or condom)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
- The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
- The subject must complete all psychological assessments required at screening and baseline.
- The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
- The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
Boston University School of Medicine
Boston, Massachusetts, 02118
University of Virginia
Charlottesville, Virginia, 22911
Dartmouth Medical School
Lebanon, New Hampshire, 03755
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).
- Conditions
- Alcoholism
- Being tested
- BBCET, Levetiracetam XR, Sugar Pill
- Keywords
- Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse
- Medical subject headings
- Alcoholism, Alcohol Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBCETBehavioural
11 BBCET sessions
BBCETBehavioural
11 BBCET Sessions
Levetiracetam XRDrug
500mg - 2000mg Once per day 16 weeks
Sugar PillDrug
500mg - 2000mg Once per day 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam XR | Active comparator | Group received Levetiracetam Receives: Behavioral: BBCET; Drug: Levetiracetam XR |
| Sugar Pill | Placebo comparator | Placebo Receives: Behavioral: BBCET; Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Measured: Weeks 5-14
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Measured: Study Weeks 5-14
Secondary outcomes (1)
The Number of Drinks Per Drinking Day Study Weeks 5-14.
based on self report
Measured: Study Weeks 5-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionOct 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 (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raye Z Litten, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)Margaret M Mattson, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)Joanne E Fertig, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970814
- Sponsor's protocol ID
- NIAAA_DTRR-2009-LITTEN-02
- Acronym
- NCIG 002
- Status last verified
- Aug 2014
- First submitted
- 1 Sep 2009
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fertig JB, Ryan ML, Falk DE, Litten RZ, Mattson ME, Ransom J, Rickman WJ, Scott C, Ciraulo D, Green AI, Tiouririne NA, Johnson B, Pettinati H, Strain EC, Devine E, Brunette MF, Kampman K, A Tompkins D, Stout R; NCIG 002 Study Group. A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Aug;36(8):1421-30. doi: 10.1111/j.1530-0277.2011.01716.x. Epub 2012 Feb 10.
PubMed 22324516
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
- ClinicalTrials.gov ID
- NCT00970814
- Acronym / sponsor ID
- NCIG 002 / NIAAA_DTRR-2009-LITTEN-02
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 6 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam XR | Active comparator | Behavioral: BBCET, Drug: Levetiracetam XRGroup received Levetiracetam |
| Sugar Pill | Placebo comparator | Behavioral: BBCET, Drug: Sugar PillPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The subject must be at least 18 years of age.
- The subject must have a DSM-IV diagnosis of current alcohol dependence.
- The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
- The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BBCET11 BBCET sessions | Behavioural | Levetiracetam XR |
| BBCET11 BBCET Sessions | Behavioural | Sugar Pill |
| Levetiracetam XR500mg - 2000mg Once per day 16 weeks | Drug | Levetiracetam XR |
| Sugar Pill500mg - 2000mg Once per day 16 weeks | Drug | Sugar Pill |
Primary outcome
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
Time frame: Weeks 5-14
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
Time frame: Study Weeks 5-14
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
1 secondary outcome
The Number of Drinks Per Drinking Day Study Weeks 5-14.
Time frame: Study Weeks 5-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22324516Fertig JB, Ryan ML, Falk DE, Litten RZ, Mattson ME, Ransom J, Rickman WJ, Scott C, Ciraulo D, Green AI, Tiouririne NA, Johnson B, Pettinati H, Strain EC, Devine E, Brunette MF, Kampman K, A Tompkins D, Stout R; NCIG 002 Study Group. A double-blind, placebo-controlled trial assessing the efficacy of levetiracetam extended-release in very heavy drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Aug;36(8):1421-30. doi: 10.1111/j.1530-0277.2011.01716.x. Epub 2012 Feb 10.
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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.
Raye Z Litten, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Margaret M Mattson, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Joanne E Fertig, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BBCET, Levetiracetam XR and Sugar Pill in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 5 sites 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 18 inclusion and 0 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 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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 6 Jul 2012). 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?
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. (time frame: Weeks 5-14). 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?
On the ClinicalTrials.gov record for NCT00970814, which also lists 1 linked publication.
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 2014.