Alcohol Dependence Clinical Trial
Official title:
An Open-Label, Sequential Study of Quetiapine Fumarate Extended Release (XR) and Mirtazapine for the Treatment of Alcohol Dependency in Very Heavy Drinkers
Verified date | March 2018 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine) is better for helping people to decrease drinking than taking one medicine alone (quetiapine).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-64 2. The subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for alcohol dependence 3. The subject is seeking treatment for alcohol dependence and desires a reduction or cessation of drinking 4. The subject is able to verbalize understanding of the consent form, able to provide written informed consent, and able to verbalize willingness to complete study procedures? 5. If the subject is female and of child bearing potential, she agrees to use an acceptable method of birth control. 6. The subject is able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits. 7. The subject is able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 8. The subject has a breath alcohol concentration (BAC) equal to 0.000 on s/he signing the informed consent document. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth Medical School Department of Psychiatry's Addition Research Center | Bedford | New Hampshire |
United States | Dartmouth Medical School Department of Psychiatry's Addiction Research Center | Hanover | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Very Heavy Drinking Days Per Week | The number of "very heavy" drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week | 14 Weeks |
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