Varenicline for Alcohol Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Johannes Gutenberg University Mainz.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01071187
First received: February 18, 2010
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Alcohol Dependence
Drug: Varenicline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of abstinent patients during the study, percentage of all patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time in days to first heavy drinking, assessed by the time-line-follow-back-interview. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in gamma-glutamyl transpeptidase levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Compliance of the subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Absolute change in the Clinical Global Impression of Change (CGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of cigarettes per day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of nicotine abstinent days, percentage of the treatment days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071187

Contacts
Contact: Markus Dr. Lorscheider, clinical coordinator +496131176103 lorscheider@psychiatrie.klinik.uni-mainz.de
Contact: Christoph Dr. Fehr, coordinating investigator +4969-9533-4000 christoph.fehr@fdk.info

Locations
Germany
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    Christoph.Fehr@fdk.info   
Principal Investigator: Christoph Fehr, PD Dr. med.         
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Markus Lorscheider, Dr. med.    +49-6131-17-6103    lorscheider@psychiatrie.klinik.uni-mainz.de   
Sub-Investigator: Markus Lorscheider, Dr. med.         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Pfizer
Investigators
Principal Investigator: Fehr Christoph, PD Dr. Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
  More Information

No publications provided

Responsible Party: PD Dr. Christoph Fehr, Department of psychiatry and psychotherapy, university medical center of the Johannes Gutenberg-university Mainz
ClinicalTrials.gov Identifier: NCT01071187     History of Changes
Other Study ID Numbers: 2009-08-17, 2009-015537-67
Study First Received: February 18, 2010
Last Updated: September 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
alcohol dependence
addiction
alcohol
relapse prevention

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014