The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
This study has been completed.
Sponsor:
Sahlgrenska University Hospital, Sweden
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00874003
First received: April 1, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 1, 2009 | ||||||||
| Last Updated Date | April 1, 2009 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Alcohol consumption measured by alcohol diary (units/week). [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers | ||||||||
| Official Title ICMJE | The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial | ||||||||
| Brief Summary | The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59). |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Alcohol Dependence | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 59 | ||||||||
| Completion Date | February 2009 | ||||||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00874003 | ||||||||
| Other Study ID Numbers ICMJE | GOTABU-BO1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Bo Söderpalm/ MD, PhD, sponsor, Addiction Biology Unit, Sahlgrenska University Hospital, Sweden | ||||||||
| Study Sponsor ICMJE | Sahlgrenska University Hospital, Sweden | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sahlgrenska University Hospital, Sweden | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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