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Alcohol DependencePhase 2NCT00846859

Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

A Phase 2 study testing varenicline (Champix/Chantix) in people with Alcohol Dependence, run by Sahlgrenska University Hospital at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Alcohol Dependence
What is being tested?
varenicline (Champix/Chantix)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
3 sitesSweden
Study dates
Mar 2009to Jan 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 30-70 years at screening
  • Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
  • ≥ 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
  • Participants must have signed the informed consent

Who cannot join

  • Subject to treatment of alcohol withdrawal within 30 days of study initiation
  • 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
  • Subject to treatment of depression within 3 months of study initiation
  • The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
  • Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
  • History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
Show all 16Show fewer
  • 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.
  • 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.
  • Any ongoing serious psychiatric or somatic disorder
  • Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
  • The concurrent use of illicit drugs based on urine-toxicity test
  • The need for detoxification
  • Diabetes Mellitus Type 1
  • Suicidal risk
  • Homelessness
  • Additional factors that implies to the investigator/physician that the participant will not be completing the study

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Beroendecentrum, Malmö University Hospital (UMAS), Sweden

    Malmö, 205 02

  • Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

About this study

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.

Being tested
varenicline (Champix/Chantix), placebo for varenicline
Keywords
alcohol dependence, nicotine dependence, alcohol abuse, varenicline, Champix, Chantix, smoking, drinking, snuffing, diary, phosphatidyl ethanol, PEth
Medical subject headings
Alcoholism, Tobacco Use Disorder, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • varenicline (Champix/Chantix)Drug

    Also called Champix(R)/Chantix(R)

    14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).

  • placebo for vareniclineDrug

    Also called placebo for Champix(R) / Chantix(R)

    14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)

Study groups in NCT00846859
Study groupRoleWhat they receive
vareniclineExperimentalNot described
Receives: Drug: varenicline (Champix/Chantix)
placeboPlacebo comparatorNot described
Receives: Drug: placebo for varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (6)

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

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

  3. Drinks per drinking day compared to baseline.

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

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

  6. Compliance as measured by diary and returned medication packages.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionAug 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00846859
Sponsor's protocol ID
GOTABU-BO2
Status last verified
Jul 2011
First submitted
17 Feb 2009
Last updated
21 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • Ericson M, Lof E, Stomberg R, Soderpalm B. The smoking cessation medication varenicline attenuates alcohol and nicotine interactions in the rat mesolimbic dopamine system. J Pharmacol Exp Ther. 2009 Apr;329(1):225-30. doi: 10.1124/jpet.108.147058. Epub 2009 Jan 6.

    PubMed 19126781

  • Lof E, Olausson P, deBejczy A, Stomberg R, McIntosh JM, Taylor JR, Soderpalm B. Nicotinic acetylcholine receptors in the ventral tegmental area mediate the dopamine activating and reinforcing properties of ethanol cues. Psychopharmacology (Berl). 2007 Dec;195(3):333-43. doi: 10.1007/s00213-007-0899-4. Epub 2007 Aug 17.

    PubMed 17703283

  • Lof E, Chau PP, Stomberg R, Soderpalm 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. doi: 10.1016/j.ejphar.2006.10.056. Epub 2006 Oct 28.

    PubMed 17141214

  • Soderpalm B, Ericson M, Olausson P, Blomqvist O, Engel JA. Nicotinic mechanisms involved in the dopamine activating and reinforcing properties of ethanol. Behav Brain Res. 2000 Aug;113(1-2):85-96. doi: 10.1016/s0166-4328(00)00203-5.

    PubMed 10942035

  • Ericson M, Blomqvist O, Engel JA, Soderpalm B. Voluntary ethanol intake in the rat and the associated accumbal dopamine overflow are blocked by ventral tegmental mecamylamine. Eur J Pharmacol. 1998 Oct 9;358(3):189-96. doi: 10.1016/s0014-2999(98)00602-5.

    PubMed 9822883

  • Blomqvist O, Ericson M, Engel JA, Soderpalm B. Accumbal dopamine overflow after ethanol: localization of the antagonizing effect of mecamylamine. Eur J Pharmacol. 1997 Sep 10;334(2-3):149-56. doi: 10.1016/s0014-2999(97)01220-x.

    PubMed 9369343

  • Blomqvist O, Soderpalm B, Engel JA. Ethanol-induced locomotor activity: involvement of central nicotinic acetylcholine receptors? Brain Res Bull. 1992 Aug;29(2):173-8. doi: 10.1016/0361-9230(92)90023-q.

    PubMed 1525672

  • Blomqvist O, Engel JA, Nissbrandt H, Soderpalm B. The mesolimbic dopamine-activating properties of ethanol are antagonized by mecamylamine. Eur J Pharmacol. 1993 Nov 9;249(2):207-13. doi: 10.1016/0014-2999(93)90434-j.

    PubMed 8287902

  • Steensland P, Simms JA, Holgate J, Richards JK, Bartlett SE. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, selectively decreases ethanol consumption and seeking. Proc Natl Acad Sci U S A. 2007 Jul 24;104(30):12518-23. doi: 10.1073/pnas.0705368104. Epub 2007 Jul 11.

    PubMed 17626178

  • Blomqvist O, Hernandez-Avila CA, Van Kirk J, Rose JE, Kranzler HR. Mecamylamine modifies the pharmacokinetics and reinforcing effects of alcohol. Alcohol Clin Exp Res. 2002 Mar;26(3):326-31.

    PubMed 11923584

  • Young EM, Mahler S, Chi H, de Wit H. Mecamylamine and ethanol preference in healthy volunteers. Alcohol Clin Exp Res. 2005 Jan;29(1):58-65. doi: 10.1097/01.alc.0000150007.34702.16.

    PubMed 15654292

  • Chi H, de Wit H. Mecamylamine attenuates the subjective stimulant-like effects of alcohol in social drinkers. Alcohol Clin Exp Res. 2003 May;27(5):780-6. doi: 10.1097/01.ALC.0000065435.12068.24.

    PubMed 12766622

  • Rollema H, Chambers LK, Coe JW, Glowa J, Hurst RS, Lebel LA, Lu Y, Mansbach RS, Mather RJ, Rovetti CC, Sands SB, Schaeffer E, Schulz DW, Tingley FD 3rd, Williams KE. Pharmacological profile of the alpha4beta2 nicotinic acetylcholine receptor partial agonist varenicline, an effective smoking cessation aid. Neuropharmacology. 2007 Mar;52(3):985-94. doi: 10.1016/j.neuropharm.2006.10.016. Epub 2006 Dec 8.

    PubMed 17157884

  • Tonstad S. Varenicline for smoking cessation. Expert Rev Neurother. 2007 Feb;7(2):121-7. doi: 10.1586/14737175.7.2.121.

    PubMed 17286546

  • Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.

    PubMed 16820547

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing varenicline (Champix/Chantix) in people with Alcohol Dependence, run by Sahlgrenska University Hospital at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00846859, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.

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