AlcoholismPhase 2NCT00406692
The Effects of Zonisamide on Alcohol Dependence
A Phase 2 study testing Zonisamide in people with Alcoholism, run by Boston University at 1 site in United States.
Trial summary
In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Zonisamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2009
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be admitted into this study patients must meet the following criteria:
- DSM IV TR Diagnosis of Alcohol Dependence; minimal level of 14 drinks per week for women or 21 drinks per week for men over a 28 day consecutive period during the 90 day period prior to the screening session.
- Male or Female 21-64 years of age.
- Able to provide informed consent and comprehend study procedures.
- Negative urine toxicological screen for opioids, psychomotor stimulants, sedative-hypnotics, and cannabinoids. If the urine tox screen was positive for any substance it may be repeated within two weeks.
- Score of >8 on the Alcohol Use Disorder Identification Test (AUDIT) during screening.
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- Must be suitable for outpatient management of alcoholism.
- Express desire to stop drinking or reduce alcohol consumption with a possible long-term goal of abstinence.
- Provide contact information for themselves or an alternate contact that the staff will call in case of missed appointment.
- Women must be postmenopausal for at least one year, be surgically sterile, be using an effective method of birth control (e.g. contraceptive injection, intrauterine device, spermicide with barrier, contraceptive patch, contraceptive ring, male partner sterilization, oral contraceptives) or completely abstinent (and agree to use one of the above mentioned methods of contraception if sexual activity is ever initiated).
- Must be able to take oral medications, adhere to the regimen and be willing to return for follow up visits.
- Must have breath alcohol concentration of no more than 0.01% when the informed consent is provided and the consent form is signed.
- Must have resided at the same address for at least 3 months.
Who cannot join
- Patients meeting the following criteria will be excluded from the study:
- 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 dependence, nicotine dependence, or caffeine dependence that in the opinion of the study physicians might require intervention with either pharmacological or non-pharmacological therapy that will 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 4 weeks prior to enrollment into this study.
- Subjects with a score of 10 or greater on the CIWA-Ar (a withdrawal scale) on first or second visits.
- Currently being treated with acamprosate, disulfiram or naltrexone.
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- Currently being treated with any of the following medications: a) Antipsychotic agents- including clozapine, risperidone, quetiapine, haloperidol b) Antimanic or anticonvulsant agents- including lithium carbonate, phenytoin, phenobarbital, carbamazepine, topiramate, valproic acid, divalproex, tiagabine c) Sedative-hypnotic or antianxiety agents-including triazolam, temazepam, zolpidem, zalepron, buspirone, alprazolam, diazepam, clonazepam, oxazepam, lorazepam d) chronic opioid treatment- including methadone, buprenorphine, oxycodone, morphine e) Psychomotor stimulants- amphetamine derivatives, methylphenidate
- Subjects who are legally mandated to participate in an alcohol treatment program
- Use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes including macrolide antibiotics, fluoxetine, and carbamazepine.
- Subjects who have attempted suicide or who have had suicidal ideation within 30 days of their first visit as assessed using responses from the SCID and Hamilton Depression scale.
- Subjects with renal disease (including severe infection and cancer), impaired renal clearance (CrCl less than 50 ml/min), or history of kidney stones.
- Subjects with AST or ALT >3 times the upper limit of the normal range during screening.
- History of significant neurological disorder, including a history of seizures, stroke, dementia, multiple sclerosis, Parkinson's disease, brain tumors, or encephalitis.
- Subjects who are pregnant (as assessed by serum HCG) or lactating.
- Subjects known to have clinically significant medical conditions. These may include: symptomatic CAD or PVD, malignancy or history of malignancy in the last 5 years, significant pulmonary disease or endocrinological disorders.
- Subjects with prior hypersensitivity to zonisamide or related compounds, including sulfonamides (e.g. sulfisoxazole) carbonic anhydrase inhibitors (e.g. acetazolamide), sulfonylureas (e.g. chlorpropamide), sulfamates (e.g. topiramate), thiazide (e.g. hydrochlorothiazide), and loop diuretics (e.g. furosemide) except ethacrycrynic acid.
- Subjects who in the opinion of the study physicians should not be enrolled based on the precautions, warnings, and contraindications stated on the package insert for zonisamide.
- Impending incarceration.
- Score of 25 or less on the Folstein Mini-Mental examination.
- History of anticonvulsant-induced rash.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.
- Conditions
- Alcoholism
- Being tested
- Zonisamide
- Keywords
- Zonisamide, Alcoholism, Alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide | Experimental | In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study Receives: Drug: Zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase
The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.
Measured: Baseline and Week 12
Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).
Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.
Measured: Week 0- Baseline and Week 12
Secondary outcomes (1)
Symbol Digit Modalities Test (DSMT)
Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionNov 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Investigators
- Clifford Knapp, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406692
- Sponsor's protocol ID
- H-25544
- Status last verified
- May 2010
- First submitted
- 30 Nov 2006
- Last updated
- 11 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Zonisamide on Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00406692
- Acronym / sponsor ID
- H-25544
- Conditions
- Alcoholism
- Keywords
- Zonisamide, Alcoholism, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Posted 6 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zonisamide | Experimental | Drug: ZonisamideIn open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- DSM IV TR Diagnosis of Alcohol Dependence; minimal level of 14 drinks per week for women or 21 drinks per week for men over a 28 day consecutive period during the 90 day period prior to the screening session.
- Male or Female 21-64 years of age.
- Able to provide informed consent and comprehend study procedures.
- Negative urine toxicological screen for opioids, psychomotor stimulants, sedative-hypnotics, and cannabinoids. If the urine tox screen was positive for any substance it may be repeated within two weeks.
- Score of >8 on the Alcohol Use Disorder Identification Test (AUDIT) during screening.
Key exclusion criteria (20 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 dependence, nicotine dependence, or caffeine dependence that in the opinion of the study physicians might require intervention with either pharmacological or non-pharmacological therapy that will 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 4 weeks prior to enrollment into this study.
- Subjects with a score of 10 or greater on the CIWA-Ar (a withdrawal scale) on first or second visits.
- Currently being treated with acamprosate, 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 |
|---|---|---|
| ZonisamideWeek 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily. | Drug | Zonisamide |
Primary outcome
The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase
Time frame: Baseline and Week 12
The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.
Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).
Time frame: Week 0- Baseline and Week 12
Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.
1 secondary outcome
Symbol Digit Modalities Test (DSMT)
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clifford Knapp, PhD 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 2 study testing Zonisamide 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 13 inclusion and 20 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 11 May 2010. 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 6 May 2010). 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 Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase (time frame: Baseline and Week 12). 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?
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 11 May 2010.