Varenicline for Alcohol Dependence

NCT01071187 | Unknown Phase 2 DMC

• 2 other identifiers: 2009-08-172009-015537-67
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; addiction; alcohol; relapse prevention

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (16)

• Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview

  12 weeks

• Proportion of abstinent patients during the study, percentage of all patients

  12 weeks

• Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.

  12 weeks

• Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.

  12 weeks

• Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.

  12 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline DRUG

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

Varenicline

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Pfizer: collaborator

Study Sites (2)

Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main

Frankfurt am Main, Hesse, 60431, Germany

RECRUITING

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Fehr Christoph, PD Dr.

  Department of psychiatry and psychotherapy, university medical center mainz of the Johannes Gutenberg-university mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Dr. Lorscheider, clinical coordinator

CONTACT

+496131176103; lorscheider@psychiatrie.klinik.uni-mainz.de

Christoph Dr. Fehr, coordinating investigator

CONTACT

+4969-9533-4000; christoph.fehr@fdk.info

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 15, 2010

Record last verified: 2010-09

Locations

DE (2)