Trial for the Treatment of Alcohol Dependence
Recruitment status was Active, not recruiting
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The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.
Condition | Intervention | Phase |
---|---|---|
Alcoholism |
Drug: Naltrexone Drug: Acamprosate |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence |
- Time (days) to relapse
- Time (days) to lapse
- Days abstinence
- Drinks per drinking day
- Biochemical measures of liver function
- Craving
- Depression
- Anxiety
- Stress
- Global physical health
- Global mental health
Estimated Enrollment: | 200 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Australia, New South Wales | |
Drug Health Services, Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2050 |
Study Chair: | Paul Haber, MBBAMDFRACP | Conjoint Associate Professor |
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00120601 History of Changes |
Other Study ID Numbers: | X99-0277, 211177 |
Study First Received: | July 11, 2005 |
Last Updated: | July 15, 2005 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by University of Sydney:
treatment alcohol dependence medication |
Additional relevant MeSH terms:
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Acamprosate Narcotic Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Alcohol Deterrents |
ClinicalTrials.gov processed this record on October 16, 2012