Varenicline for Alcohol Dependence

Alcohol Dependence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01071187
• Other study ID #: 2009-08-17
• Secondary ID: 2009-015537-67
• Status: Recruiting
• Phase: Phase 2
• First received: February 18, 2010
• Last updated: September 14, 2010
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: Johannes Gutenberg University Mainz
• Contact: Markus Dr. Lorscheider, clinical coordinator
• Phone: +496131176103
• Email: lorscheider[@]psychiatrie.klinik.uni-mainz.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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
Placebo

Locations

Country	Name	City	State
Germany	Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main	Frankfurt am Main	Hessen
Germany	Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz	Mainz	Rheinland-Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

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