ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
+496131176103
- diagnosis of alcohol dependence according to DSM IV
- 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
- alcohol withdrawal delirium during last alcohol detoxification
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Varenicline for Alcohol Dependence | |||
Official Title ICMJE | Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study | |||
Brief Summary | The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Alcohol Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE | 40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | September 2011 | |||
Estimated Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01071187 | |||
Other Study ID Numbers ICMJE | 2009-08-17 2009-015537-67 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | PD Dr. Christoph Fehr, Department of psychiatry and psychotherapy, university medical center of the Johannes Gutenberg-university Mainz | |||
Study Sponsor ICMJE | Johannes Gutenberg University Mainz | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Johannes Gutenberg University Mainz | |||
Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |