AlcoholismPhase 1NCT00769158
Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
A Phase 1 study testing Topiramate and Naltrexone in people with Alcoholism, run by Bankole Johnson at 2 sites in United States.
Trial summary
We propose to conduct an inpatient pilot study to test the safety and potential efficacy of topiramate and naltrexone in combination for the treatment of alcoholism. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Topiramate and Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV-R diagnosis of alcohol dependence.
- Currently drinking.
- Good physical health as determined by a complete physical examination, electrocardiogram within normal limits
- Negative pregnancy test at intake. Women of childbearing potential will be placed on oral contraceptives and also will be expected to use barrier and spermicide as an additional form of contraception if sexually active.
- Literate in English language, and able to read, understand, and complete rating scales and questionnaires accurately.
- Willingness to comply with study procedures and protocol including agreement to overnight stay at the human laboratory. Compliance with the alcohol, tobacco, and drug-free environment regulations at the human laboratory is also a condition of enrollment.
- Written informed consent.
Who cannot join
- Expression of desire for immediate treatment for alcohol or drug addiction.
- History of mental illness that warrants treatment or would preclude safe participation in the protocol except nicotine dependence, as determined by mental status and psychiatric interview using the Structured Clinical Interview for DSM-IV.
- Acute or chronic organic brain syndrome, schizophrenia, bipolar disorder, or any psychotic disorder.
- Significant medical illness as determined by history and/or complete physical examination.
- Uncontrolled uterine or cervical bleeding.
- History of blood clots.
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- Past problems with oral contraceptive pills.
- Gross neurological disease.
- Mental retardation.
- Neurocognitive functioning >1.5 standard deviation below expected range. If neurocognitive functioning test is >1.5 standard deviation below expected range
- Clinically significant abnormalities on the electrocardiogram
- History of ischemic heart disease or myocardial infarction.
- History of glaucoma or uncontrolled symptomatic thyroid disease.
- Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.
- Positive pregnancy test.
- Women 35 and above who smoke will be excluded from participating in this research study.
- Participation in a human laboratory or clinical study within the last 30 days.
- Clinically significant laboratory screening test (LST) results on hematology, chemistry, or urine analysis.
- History of any severe or life-threatening reaction to topiramate or naltrexone
- Past or current history of seizures disorder.
- Past or current history of kidney stones.
- Use of any carbonic anhydrase medication.
- Being treated with any medication with potential interactions with alcohol or naltrexone.
- Pending imprisonment.
- For smokers, previous adverse reaction to nicotine patch
- Reporting no experience of craving for alcohol
- Postmenopausal women will not be recruited into this study.
- Chronic use of NSAIDs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UVA CARE
Charlottesville, Virginia, 22911
UVA CARE Richmond
Richmond, Virginia, 23294
About this study
We propose to conduct an inpatient pilot study to test the safety and potential efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.
Read the detailed description
Eight (n = 8) alcohol-dependent research volunteers, not seeking treatment, will complete a placebo-controlled, within-subject cross-over design in which alcohol-related and control cues are presented as stimuli to induce alcohol-seeking behavior under controlled laboratory conditions after repeated dose (chronic) treatment with double-blind doses of placebo or topiramate + naltrexone.Subjects will reside in an inpatient environment for two separate 9-day blocks interspersed by a 1-week washout period. During separate blocks, topiramate + naltrexone and placebo doses will be administered orally on a twice-daily regimen (08:00 h and 20:00 h) for 8 days.Doses will start the evening of day 1 and the last dose will be given the morning of day 8. No doses will be given the evening of day 8 or the morning of day 9. On Days 7 and 8 of the dosing regimen, subjects will receive alcohol and alcohol-related cues or the corresponding control cues.
- Conditions
- Alcoholism
- Being tested
- Topiramate and Naltrexone, Placebo
- Keywords
- Alcohol, Alcoholism, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate and NaltrexoneDrug
Also called Topamax and Revia
Topiramate 200 mg and Naltrexone 50 mg
PlaceboOther
Also called Sugar Pill
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Topiramate + Naltrexone | Experimental | Combination of Topiramate and Naltrexone Receives: Drug: Topiramate and Naltrexone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of this novel combination of topiramate and naltrexone. To evaluate the efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bankole Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bankole Johnson, University of Virginia
- Investigators
- Bankole Johnson, DSc,MD.PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769158
- Sponsor's protocol ID
- 13521
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2008
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
- ClinicalTrials.gov ID
- NCT00769158
- Acronym / sponsor ID
- 13521
- Conditions
- Alcoholism
- Keywords
- Alcohol, Alcoholism, Alcohol Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bankole JohnsonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to conduct an inpatient pilot study to test the safety and potential efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.
Detailed description
Eight (n = 8) alcohol-dependent research volunteers, not seeking treatment, will complete a placebo-controlled, within-subject cross-over design in which alcohol-related and control cues are presented as stimuli to induce alcohol-seeking behavior under controlled laboratory conditions after repeated dose (chronic) treatment with double-blind doses of placebo or topiramate + naltrexone.Subjects will reside in an inpatient environment for two separate 9-day blocks interspersed by a 1-week washout period. During separate blocks, topiramate + naltrexone and placebo doses will be administered orally on a twice-daily regimen (08:00 h and 20:00 h) for 8 days.Doses will start the evening of day 1 and the last dose will be given the morning of day 8. No doses will be given the evening of day 8 or the morning of day 9. On Days 7 and 8 of the dosing regimen, subjects will receive alcohol and alcohol-related cues or the corresponding control cues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate + Naltrexone | Experimental | Drug: Topiramate and NaltrexoneCombination of Topiramate and Naltrexone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM-IV-R diagnosis of alcohol dependence.
- Currently drinking.
- Good physical health as determined by a complete physical examination, electrocardiogram within normal limits
- Negative pregnancy test at intake. Women of childbearing potential will be placed on oral contraceptives and also will be expected to use barrier and spermicide as an additional form of contraception if sexually active.
- Literate in English language, and able to read, understand, and complete rating scales and questionnaires accurately.
Key exclusion criteria (28 listed)
- Expression of desire for immediate treatment for alcohol or drug addiction.
- History of mental illness that warrants treatment or would preclude safe participation in the protocol except nicotine dependence, as determined by mental status and psychiatric interview using the Structured Clinical Interview for DSM-IV.
- Acute or chronic organic brain syndrome, schizophrenia, bipolar disorder, or any psychotic disorder.
- Significant medical illness as determined by history and/or complete physical examination.
- Uncontrolled uterine or cervical bleeding.
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 |
|---|---|---|
| Topiramate and NaltrexoneAlso: Topamax and ReviaTopiramate 200 mg and Naltrexone 50 mg | Drug | Topiramate + Naltrexone |
| PlaceboAlso: Sugar PillPlacebo Comparator | Other | Placebo |
Primary outcome
To assess the safety of this novel combination of topiramate and naltrexone. To evaluate the efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
Bankole Johnson, DSc,MD.PhD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topiramate and Naltrexone in people with Alcoholism, run by Bankole Johnson at 2 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 7 inclusion and 28 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 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety of this novel combination of topiramate and naltrexone. To evaluate the efficacy of topiramate and naltrexone in combination for the treatment of alcoholism. (time frame: Throughout the study). 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 7 Feb 2012.