Varenicline for Alcohol Dependence

NCT01071187

Last updated date
Study Location
Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
Frankfurt am Main, Hessen, 60431, Germany
Contact
+496131176103

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alcohol Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Alcohol DependenceVarenicline for Alcohol Dependence
NCT01071187
  1. Frankfurt am Main, Hessen
  2. Mainz, Rheinland-Pfalz
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: Varenicline
    Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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
 (submitted: February 18, 2010)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Fehr Christoph, PD Dr.Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
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