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Varenicline for Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Varenicline
Placebo
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, addiction, alcohol, relapse prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am MainRecruiting
  • Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university MainzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Varenicline

Placebo

Arm Description

Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84.

Outcomes

Primary Outcome Measures

Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2010
Last Updated
September 14, 2010
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01071187
Brief Title
Varenicline for Alcohol Dependence
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcohol dependence, addiction, alcohol, relapse prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Experimental
Arm Description
Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Varenicline
Intervention Description
Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview
Time Frame
12 weeks
Title
Proportion of abstinent patients during the study, percentage of all patients
Time Frame
12 weeks
Title
Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.
Time Frame
12 weeks
Title
Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.
Time Frame
12 weeks
Title
Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.
Time Frame
12 weeks
Title
Changes in gamma-glutamyl transpeptidase levels
Time Frame
12 weeks
Title
Occurrence of adverse events
Time Frame
12 weeks
Title
Compliance of the subjects
Time Frame
12 weeks
Title
alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)
Time Frame
12 weeks
Title
Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)
Time Frame
12 weeks
Title
Absolute change in the Clinical Global Impression of Change (CGI)
Time Frame
12 weeks
Title
Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)
Time Frame
12 weeks
Title
Number of cigarettes per day
Time Frame
12 weeks
Title
Number of nicotine abstinent days, percentage of the treatment days
Time Frame
12 weeks
Title
Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence
Time Frame
12 weeks
Title
Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Dr. Lorscheider, clinical coordinator
Phone
+496131176103
Email
lorscheider@psychiatrie.klinik.uni-mainz.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Dr. Fehr, coordinating investigator
Phone
+4969-9533-4000
Email
christoph.fehr@fdk.info
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fehr Christoph, PD Dr.
Organizational Affiliation
Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60431
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Fehr, PD Dr. med.
Phone
+49-69-9533-4000
Email
Christoph.Fehr@fdk.info
First Name & Middle Initial & Last Name & Degree
Christoph Fehr, PD Dr. med.
Facility Name
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Lorscheider, Dr. med.
Phone
+49-6131-17-6103
Email
lorscheider@psychiatrie.klinik.uni-mainz.de
First Name & Middle Initial & Last Name & Degree
Markus Lorscheider, Dr. med.

12. IPD Sharing Statement

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Varenicline for Alcohol Dependence

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