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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Malmö University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline (Champix/Chantix) | Drug | 14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elin Löf, PhD | Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden | Study Director |
| Bo Söderpalm, MD, PhD | Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19126781 | Background | 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. | |
| 17703283 | Background | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo for varenicline | Drug | 14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day) |
|
|
| 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. |
| Beroendecentrum, Malmö University Hospital (UMAS), Sweden |
| Malmö |
| 205 02 |
| Sweden |
| Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital | Stockholm | 171 76 | Sweden |
| 17141214 | Background | 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. |
| 10942035 | Background | 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. |
| 9822883 | Background | 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. |
| 9369343 | Background | 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. |
| 1525672 | Background | 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. |
| 8287902 | Background | 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. |
| 17626178 | Background | 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. |
| 11923584 | Background | 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. |
| 15654292 | Background | 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. |
| 12766622 | Background | 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. |
| 17157884 | Background | 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. |
| 17286546 | Background | Tonstad S. Varenicline for smoking cessation. Expert Rev Neurother. 2007 Feb;7(2):121-7. doi: 10.1586/14737175.7.2.121. |
| 16820547 | Background | 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. |
| 17374627 | Background | Gonzales D, Rennard SI, Jorenby DE, Reeves KR. Comment: Oral varenicline for smoking cessation. Ann Pharmacother. 2007 Apr;41(4):720-1. doi: 10.1345/aph.1H310a. Epub 2007 Mar 20. No abstract available. |
| 10787393 | Background | Daeppen JB, Smith TL, Danko GP, Gordon L, Landi NA, Nurnberger JI Jr, Bucholz KK, Raimo E, Schuckit MA. Clinical correlates of cigarette smoking and nicotine dependence in alcohol-dependent men and women. The Collaborative Study Group on the Genetics of Alcoholism. Alcohol Alcohol. 2000 Mar-Apr;35(2):171-5. doi: 10.1093/alcalc/35.2.171. |
| 15902919 | Background | Larsson A, Jerlhag E, Svensson L, Soderpalm B, Engel JA. Is an alpha-conotoxin MII-sensitive mechanism involved in the neurochemical, stimulatory, and rewarding effects of ethanol? Alcohol. 2004 Oct-Nov;34(2-3):239-50. doi: 10.1016/j.alcohol.2004.10.002. |
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| D001519 | Behavior |
| D011810 | Quinoxalines |