Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Condition(s) targeted: Alcohol Dependence

Intervention: varenicline (Champix/Chantix) (Drug); placebo for varenicline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sahlgrenska University Hospital, Sweden

Official(s) and/or principal investigator(s):
Elin Löf, PhD, Study Director, Affiliation: Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden
Bo Söderpalm, MD, PhD, Principal Investigator, Affiliation: Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden

Overall contact:
Elin Löf, PhD, Phone: +46-31-342, Ext: 4223, Email: elin.lof@neuro.gu.se

The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.

Official title: Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women

Secondary outcome:

Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline.

Percentage (and number) of abstaining days compared to baseline.

Drinks per drinking day compared to baseline.

Alcohol consumption as measured by alcohol markers in blood compared to baseline.

Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline.

Compliance as measured by diary and returned medication packages.

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Age: 30-70 years at screening

2. Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)

3. ≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days

4. Participants must have signed the informed consent

Exclusion Criteria:

1. Subject to treatment of alcohol withdrawal within 30 days of study initiation

2. Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation

3. Subject to treatment of depression within 3 months of study initiation

4. The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)

5. Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial

6. History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures

7. Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values.

8. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.

9. Any ongoing serious psychiatric or somatic disorder

10. Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)

11. The concurrent use of illicit drugs based on urine-toxicity test

12. The need for detoxification

13. Diabetes Mellitus Type 1

14. Suicidal risk

15. Homelessness

16. Additional factors that implies to the investigator/physician that the participant will not be completing the study

Elin Löf, PhD, Phone: +46-31-342, Ext: 4223, Email: elin.lof@neuro.gu.se

Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg 413 45, Sweden; Recruiting
Elin Löf, PhD, Email: elin.lof@neuro.gu.se
Elin Löf, PhD, Sub-Investigator
Andrea deBejczy, MD, Sub-Investigator
Bo Söderpalm, MD, PhD, Principal Investigator

Beroendecentrum, Malmö University Hospital (UMAS), Sweden, Malmö 205 02, Sweden; Recruiting
Birgitta Glanrup, Email: birgitta.glanrup@skane.se
Birgitta Glanrup, Sub-Investigator
Gulber Asanovska, MD, Principal Investigator

Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital, Stockholm 171 76, Sweden; Recruiting
Anders Hammarberg, Email: anders.hammarberg@ki.se
Anders Hammarberg, Sub-Investigator
Johan Franck, MD, PhD, Principal Investigator

Related publications:

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Löf E, Chau PP, Stomberg R, Söderpalm B. Ethanol-induced dopamine elevation in the rat--modulatory effects by subchronic treatment with nicotinic drugs. Eur J Pharmacol. 2007 Jan 26;555(2-3):139-47. Epub 2006 Oct 28.

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Starting date: March 2009
Last updated: April 16, 2010