Clinical trial NCT01071187: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alcohol Dependence
Keywords: alcohol dependence
addiction
alcohol
relapse prevention
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
timeFrame: 12 weeks
Secondary outcomes:
measure: Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview
timeFrame: 12 weeks
measure: Proportion of abstinent patients during the study, percentage of all patients
timeFrame: 12 weeks
measure: Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.
timeFrame: 12 weeks
measure: Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.
timeFrame: 12 weeks
measure: Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.
timeFrame: 12 weeks
measure: Changes in gamma-glutamyl transpeptidase levels
timeFrame: 12 weeks
measure: Occurrence of adverse events
timeFrame: 12 weeks
measure: Compliance of the subjects
timeFrame: 12 weeks
measure: alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)
timeFrame: 12 weeks
measure: Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)
timeFrame: 12 weeks
measure: Absolute change in the Clinical Global Impression of Change (CGI)
timeFrame: 12 weeks
measure: Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)
timeFrame: 12 weeks
measure: Number of cigarettes per day
timeFrame: 12 weeks
measure: Number of nicotine abstinent days, percentage of the treatment days
timeFrame: 12 weeks
measure: Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence
timeFrame: 12 weeks
measure: Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main
state: Hessen
city: Mainz
country: Germany
facility: Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz
name: Fehr Christoph, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: