AlcoholismPhase 4NCT00120601
Trial for the Treatment of Alcohol Dependence
A Phase 4 study testing Naltrexone and Acamprosate in people with Alcoholism, run by University of Sydney at 1 site in Australia.
Trial summary
The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Naltrexone and Acamprosate
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2003to Jun 2005
- Phase
- Phase 4
- 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
- Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
- Ages 18-65
- Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
- Willingness to give written informed consent
- Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal
Who cannot join
- Opiate abuse within the last one month
- Sensitivity to study medications or therapy with these drugs within 6 months
- Active major psychiatric disorder associated with psychosis or significant suicide risk
- Pregnancy or lactation
- Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.
Read the detailed description
The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.
- Conditions
- Alcoholism
- Being tested
- Naltrexone, Acamprosate
- Keywords
- treatment, alcohol, dependence, medication
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
AcamprosateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) to relapse
Time (days) to lapse
Days abstinence
Drinks per drinking day
Biochemical measures of liver function
Secondary outcomes (6)
Craving
Depression
Anxiety
Stress
Global physical health
Global mental health
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startMar 2003
- Study completionJun 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South Eastern Area Health Service, Wentworth Area Health Services
- Investigators
- Paul Haber, MBBAMDFRACP, Study chair, Conjoint Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120601
- Sponsor's protocol ID
- X99-0277
- Other IDs
- 211177
- Status last verified
- Jun 2005
- First submitted
- 11 Jul 2005
- Last updated
- 18 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00120601
- Acronym / sponsor ID
- X99-0277
- Conditions
- Alcoholism
- Keywords
- treatment, alcohol, dependence, medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South Eastern Area Health Service, Wentworth Area Health Services
- Study start
- Mar 2003
- Study completion
- Jun 2005
- First posted
- 18 Jul 2005 (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.
The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.
Detailed description
The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (5 listed)
- Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
- Ages 18-65
- Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
- Willingness to give written informed consent
- Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal
Key exclusion criteria (5 listed)
- Opiate abuse within the last one month
- Sensitivity to study medications or therapy with these drugs within 6 months
- Active major psychiatric disorder associated with psychosis or significant suicide risk
- Pregnancy or lactation
- Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)
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 |
|---|---|---|
| Naltrexone | Drug | – |
| Acamprosate | Drug | – |
Primary outcome
Time (days) to relapse
Time (days) to lapse
Days abstinence
Drinks per drinking day
Biochemical measures of liver function
6 secondary outcomes
Craving
Depression
Anxiety
Stress
Global physical health
Global mental health
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2005.
- Click here for more information about this study: The Alcohol Pharmacotherapy Project. This study is run through the University of Sydney.Link provided by the sponsor.
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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.
Paul Haber, MBBAMDFRACP study chair
Conjoint Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone and Acamprosate in people with Alcoholism, run by University of Sydney at 1 site in Australia.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jul 2005. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time (days) to relapse. The study lists 5 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 18 Jul 2005.