AlcoholismPhase 3NCT00768508
Combined Pharmacotherapies for Alcoholism
A Phase 3 study testing Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy, Naltrexone 50 mg/day + Cognitive Behavioral Therapy and Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy in people with Alcoholism, run by Bankole Johnson at 2 sites in United States.
Trial summary
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy, Naltrexone 50 mg/day + Cognitive Behavioral Therapy and Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Dec 2012
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent.
- Ages 18 years and above and must weigh at least 40 kg and no more than 140 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see exclusion criteria).
- Current DSM-IV diagnosis of alcohol dependence
- AUDIT score of equal or more than 8.
- Currently drinking
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- Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months.
- The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
- Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
- Answer an advertisement in the newspaper/radio/television, or be referred from a health care professional and express a wish to stop drinking.
- Willingness to participate in behavioral treatments for alcoholism.
Who cannot join
- Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine dependence
- Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal range, or clinically significant elevated direct bilirubin as deemed by the principal investigator.
- Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient treatment.
- Serious medical co-morbidity requiring medical intervention or close supervision, or any condition which can interfere with the receipt of ondansetron.
- Severe or life-threatening adverse reactions to medications in the past or during this clinical trial.
- Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
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- Received inpatient or outpatient treatment for alcohol dependence within the last 30 days (support groups such as AA are not exclusionary).
- Compelled to participate in an alcohol treatment program to maintain their liberty.
- Members of the same household.
- Concurrent treatment with any medications having a potential effect on alcohol consumption and related behaviors, or mood. These include: opiate antagonist (e.g. naltrexone), glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g. fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other antidepressants (e.g. tricylic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g. isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.
- Before double-blind randomization, urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
- Pyrexia of unknown origin
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
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
Read the detailed description
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
- Conditions
- Alcoholism
- Being tested
- Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy, Naltrexone 50 mg/day + Cognitive Behavioral Therapy, Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy, Placebo + Cognitive Behavioral Therapy
- Keywords
- Alcohol, Alcohol Dependence, Alcoholism
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyDrug
Also called Zofran
Ondansetron 4 ug/kg b.i.d.for 12 weeks
Naltrexone 50 mg/day + Cognitive Behavioral TherapyDrug
Also called Revia
Naltrexone 50 mg/day for 12 weeks
Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral TherapyDrug
Also called Zofran and Revia
Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
Placebo + Cognitive Behavioral TherapyOther
Also called sugar pill
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy Receives: Drug: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy |
| Naltrexone | Experimental | Naltrexone 50 mg/day + Cognitive Behavioral Therapy Receives: Drug: Naltrexone 50 mg/day + Cognitive Behavioral Therapy |
| Ondansetron + Naltrexone | Experimental | Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy Receives: Drug: Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy |
| Placebo | Placebo comparator | Placebo + Cognitive Behavioral Therapy Receives: Other: Placebo + Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Measured: Throughout the study
Secondary outcomes (1)
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Pill Count, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
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 startSep 2008
- Primary completionDec 2012
- Study completionDec 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bankole Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- 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
- NCT00768508
- Sponsor's protocol ID
- 12790
- Other IDs
- R01AA012964
- Status last verified
- Mar 2013
- First submitted
- 6 Oct 2008
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pharmacotherapies for Alcoholism
- ClinicalTrials.gov ID
- NCT00768508
- Acronym / sponsor ID
- 12790
- Conditions
- Alcoholism
- Keywords
- Alcohol, Alcohol Dependence, Alcoholism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bankole JohnsonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (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.
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
Detailed description
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy |
| Naltrexone | Experimental | Drug: Naltrexone 50 mg/day + Cognitive Behavioral TherapyNaltrexone 50 mg/day + Cognitive Behavioral Therapy |
| Ondansetron + Naltrexone | Experimental | Drug: Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral TherapyOndansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy |
| Placebo | Placebo comparator | Other: Placebo + Cognitive Behavioral TherapyPlacebo + Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females who have given written informed consent.
- Ages 18 years and above and must weigh at least 40 kg and no more than 140 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see exclusion criteria).
- Current DSM-IV diagnosis of alcohol dependence
- AUDIT score of equal or more than 8.
Key exclusion criteria (12 listed)
- Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine dependence
- Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal range, or clinically significant elevated direct bilirubin as deemed by the principal investigator.
- Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient treatment.
- Serious medical co-morbidity requiring medical intervention or close supervision, or any condition which can interfere with the receipt of ondansetron.
- Severe or life-threatening adverse reactions to medications in the past or during this clinical trial.
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 |
|---|---|---|
| Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyAlso: ZofranOndansetron 4 ug/kg b.i.d.for 12 weeks | Drug | Ondansetron |
| Naltrexone 50 mg/day + Cognitive Behavioral TherapyAlso: ReviaNaltrexone 50 mg/day for 12 weeks | Drug | Naltrexone |
| Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral TherapyAlso: Zofran and ReviaCombination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks | Drug | Ondansetron + Naltrexone |
| Placebo + Cognitive Behavioral TherapyAlso: sugar pillPlacebo comparator | Other | Placebo |
Primary outcome
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Time frame: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
1 secondary outcome
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
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 15 Mar 2013.
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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 3 study testing Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy, Naltrexone 50 mg/day + Cognitive Behavioral Therapy and Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy 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 11 inclusion and 12 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 15 Mar 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption (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 15 Mar 2013.