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Varenicline for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071187
Recruitment Status : Unknown
Verified September 2010 by Johannes Gutenberg University Mainz.
Recruitment status was:  Recruiting
First Posted : February 19, 2010
Last Update Posted : September 15, 2010
Information provided by:
Johannes Gutenberg University Mainz

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Varenicline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Varenicline
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview [ Time Frame: 12 weeks ]
  2. Proportion of abstinent patients during the study, percentage of all patients [ Time Frame: 12 weeks ]
  3. Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview. [ Time Frame: 12 weeks ]
  4. Time in days to first heavy drinking, assessed by the time-line-follow-back-interview. [ Time Frame: 12 weeks ]
  5. Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview. [ Time Frame: 12 weeks ]
  6. Changes in gamma-glutamyl transpeptidase levels [ Time Frame: 12 weeks ]
  7. Occurrence of adverse events [ Time Frame: 12 weeks ]
  8. Compliance of the subjects [ Time Frame: 12 weeks ]
  9. alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS) [ Time Frame: 12 weeks ]
  10. Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI) [ Time Frame: 12 weeks ]
  11. Absolute change in the Clinical Global Impression of Change (CGI) [ Time Frame: 12 weeks ]
  12. Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12) [ Time Frame: 12 weeks ]
  13. Number of cigarettes per day [ Time Frame: 12 weeks ]
  14. Number of nicotine abstinent days, percentage of the treatment days [ Time Frame: 12 weeks ]
  15. Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence [ Time Frame: 12 weeks ]
  16. Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071187

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Contact: Markus Dr. Lorscheider, clinical coordinator +496131176103
Contact: Christoph Dr. Fehr, coordinating investigator +4969-9533-4000

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Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main Recruiting
Frankfurt am Main, Hessen, Germany, 60431
Contact: Christoph Fehr, PD Dr. med.    +49-69-9533-4000   
Principal Investigator: Christoph Fehr, PD Dr. med.         
Department of psychiatry and psychotherapy, University medical center of the Johannes Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Markus Lorscheider, Dr. med.    +49-6131-17-6103   
Sub-Investigator: Markus Lorscheider, Dr. med.         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
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Principal Investigator: Fehr Christoph, PD Dr. Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
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Responsible Party: PD Dr. Christoph Fehr, Department of psychiatry and psychotherapy, university medical center of the Johannes Gutenberg-university Mainz Identifier: NCT01071187    
Other Study ID Numbers: 2009-08-17
2009-015537-67 ( EudraCT Number )
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010
Keywords provided by Johannes Gutenberg University Mainz:
alcohol dependence
relapse prevention
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs