AlcoholismPhase 2NCT00027079
Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
A Phase 2 study testing ondansetron (Zofran), naltrexone (ReVia) and Cognitive Behavioral Therapy in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- ondansetron (Zofran), naltrexone (ReVia) and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2004
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of alcohol dependence.
- Provide a written informed consent.
- Must weigh within 30% of their ideal body weight.
- Patients must weigh at least 89 lbs. and no more than 342 lbs.
- Good physical health.
- Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
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- Provide evidence of stable residence in the last month prior to enrollment in the study.
- No plans to move in the nine months after entering the study.
- Literate in English and able to read, understand, and complete questionnaires and follow instructions.
- Willingness to participate in behavioral treatment for alcoholism.
Who cannot join
- Current psychiatric disorder other than alcohol or nicotine dependence.
- Elevated liver enzymes or elevated bilirubin.
- Severe alcohol withdrawal symptoms which require treatment.
- Serious medical co-morbidity requiring medical intervention or close supervision.
- Severe or life-threatening adverse reactions to medications in the past or during this 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.
- Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
- Members of the same household.
- Tuberculosis.
- Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
- Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
- Pyrexia of unknown origin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.
- Conditions
- Alcoholism
- Being tested
- ondansetron (Zofran), naltrexone (ReVia), Cognitive Behavioral Therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetron (Zofran)Drug
naltrexone (ReVia)Drug
Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2001 (estimated)
- Study startSep 2001
- Study completionAug 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027079
- Sponsor's protocol ID
- NIAAAJOH12964
- Status last verified
- Dec 2007
- First submitted
- 20 Nov 2001
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
- ClinicalTrials.gov ID
- NCT00027079
- Acronym / sponsor ID
- NIAAAJOH12964
- Conditions
- Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- Aug 2004 (actual)
- First posted
- 21 Nov 2001 (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 will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Current diagnosis of alcohol dependence.
- Provide a written informed consent.
- Must weigh within 30% of their ideal body weight.
- Patients must weigh at least 89 lbs. and no more than 342 lbs.
- Good physical health.
Key exclusion criteria (13 listed)
- Current psychiatric disorder other than alcohol or nicotine dependence.
- Elevated liver enzymes or elevated bilirubin.
- Severe alcohol withdrawal symptoms which require treatment.
- Serious medical co-morbidity requiring medical intervention or close supervision.
- Severe or life-threatening adverse reactions to medications in the past or during this 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 (Zofran) | Drug | – |
| naltrexone (ReVia) | Drug | – |
| Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 10 Dec 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ondansetron (Zofran), naltrexone (ReVia) and Cognitive Behavioral Therapy in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 10 inclusion and 13 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 10 Dec 2007. 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?
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.
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 10 Dec 2007.