Phase 2
Completed N=20
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
Source: ClinicalTrials.gov NCT01165541 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Number of Very Heavy Drinking Days Per Week — 2.1; 1.3 days
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Very Heavy Drinking Days Per Week |
2.1; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-64
- The subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for alcohol dependence
- The subject is seeking treatment for alcohol dependence and desires a reduction or cessation of drinking
- 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?
- If the subject is female and of child bearing potential, she agrees to use an acceptable method of birth control.
- The subject is able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
- The subject is able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- The subject has a breath alcohol concentration (BAC) equal to 0.000 on s/he signing the informed consent document.
Data sourced from ClinicalTrials.gov (NCT01165541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.