Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2010-03-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Varenicline
Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84.
Varenicline
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
Placebo
Placebo
Placebo
Interventions
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Varenicline
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* inpatient or outpatient
* last alcohol consumption within 7-21 days before randomisation
* subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation
* diagnosis of nicotine dependence according to DSM IV
* sufficient knowledge of the german language
* subject is able to follow verbal and written instructions
* subject is enabled to consent
* ability of subject to understand character and individual consequences of the clinical trial
* signed and dated informed consent of the subject must bei available before start of any specific trial procedures
* subject must have a clearly stated desire to stay abstinent
* women who are postmenopausal for more than two years or women with childbearing potential who practicing two years can participate in the study
Exclusion Criteria
* alcohol induced dementia
* severe renal insufficiency
* detoxification against subject's will
* women who are pregnant or breastfeeding or planning to become pregnant during the trial
* women with childbearing potential who not practicing a medically accepted contraception during the trial
* subjects with a known psychiatric disorder requiring treatment including a major depressive disorder, a substance dependence or abuse (besides nicotine, alcohol and cannabis)a psychosis or a dissocial personality disorder according to DSM-IV
* elevated suicide risk, defined as one positive question in the suicide section of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
* subjects with acute depression, defined as a HAMD17 (german version) sum score \> 9 or a BDI (german version) sum score \> 12
* clinically relevant acute or chronic progressive neurologic, gastrointestinel, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
* severe infection, a alcohol-induced hepatitis or a uncontrolled arterial hypertension
* use of any medication that can effect on alcohol consumption within 14 days of study initiation including antidepressants, antipsychotics, anticonvulsives, benzodiazepines (besides given in the contect of the detoxification program, anticraving drugs as naltrexone, acamprosate and disulfiram and nicotine substitutes
* subjects with following lab parameters: AST upper fivehold normal limit, PTT \< 50%, leucocytes \<2/nl, haemoglobin \< 9g/dl, thrombocytes \< 80/nl, creatinine \> 1,5mg/dl and creatinine clearance \< 30ml/min
* history of cancer in 5 last years
* known allergy against ingredient of study drug
* history of myocardial infarction or stroke
* participation in a clinical trial during last 90 days prior to screening
* clinically relevant visual disturbance or ear disease
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Department of psychiatry and psychotherapy, university medical center of the Johannes Gutenberg-university Mainz
Principal Investigators
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Fehr Christoph, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
Locations
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Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz
Mainz, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-015537-67
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2009-08-17
Identifier Type: -
Identifier Source: org_study_id