The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial
Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, litt...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2017-01, Vol.18 (1), p.14, Article 14 |
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| creator | Zahid, Raana Dogar, Omara Mansoor, Sonia Khan, Amina Kanaan, Mona Jawad, Mohammed Ahluwalia, Jasjit S Siddiqi, Kamran |
| description | Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers.
This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of |
| doi_str_mv | 10.1186/s13063-016-1761-y |
| format | Article |
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This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes.
This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention.
ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-016-1761-y</identifier><identifier>PMID: 28077163</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Abstinence ; Adults ; Affect - drug effects ; Behavior Therapy - methods ; Cigarettes ; Clinical Protocols ; Clinical trials ; Combined Modality Therapy ; Consent ; Double-Blind Method ; Drug therapy ; Health aspects ; Hookahs ; Hospitals ; Humans ; Methods ; Nicotine ; Nicotinic Agonists - adverse effects ; Nicotinic Agonists - therapeutic use ; Pakistan ; Patient outcomes ; Public health ; Recurrence ; Research Design ; Smokers - psychology ; Smoking cessation ; Smoking Cessation - methods ; Smoking Cessation - psychology ; Smoking Water Pipes ; Study Protocol ; Time Factors ; Tobacco ; Tobacco Use Cessation Devices - adverse effects ; Tobacco, Waterpipe - adverse effects ; Treatment Outcome ; Varenicline ; Varenicline - adverse effects ; Varenicline - therapeutic use ; Water pipes</subject><ispartof>Current controlled trials in cardiovascular medicine, 2017-01, Vol.18 (1), p.14, Article 14</ispartof><rights>COPYRIGHT 2017 BioMed Central Ltd.</rights><rights>The Author(s). 2017. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s). 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-e7b064568b22979b3905fd27ba0c5c5aff06ef2fbb03e83d81551922392b5fa93</citedby><cites>FETCH-LOGICAL-c494t-e7b064568b22979b3905fd27ba0c5c5aff06ef2fbb03e83d81551922392b5fa93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225555/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225555/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28077163$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zahid, Raana</creatorcontrib><creatorcontrib>Dogar, Omara</creatorcontrib><creatorcontrib>Mansoor, Sonia</creatorcontrib><creatorcontrib>Khan, Amina</creatorcontrib><creatorcontrib>Kanaan, Mona</creatorcontrib><creatorcontrib>Jawad, Mohammed</creatorcontrib><creatorcontrib>Ahluwalia, Jasjit S</creatorcontrib><creatorcontrib>Siddiqi, Kamran</creatorcontrib><title>The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers.
This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes.
This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention.
ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.</description><subject>Abstinence</subject><subject>Adults</subject><subject>Affect - drug effects</subject><subject>Behavior Therapy - methods</subject><subject>Cigarettes</subject><subject>Clinical Protocols</subject><subject>Clinical trials</subject><subject>Combined Modality Therapy</subject><subject>Consent</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Health aspects</subject><subject>Hookahs</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Methods</subject><subject>Nicotine</subject><subject>Nicotinic Agonists - adverse effects</subject><subject>Nicotinic Agonists - therapeutic use</subject><subject>Pakistan</subject><subject>Patient outcomes</subject><subject>Public health</subject><subject>Recurrence</subject><subject>Research Design</subject><subject>Smokers - psychology</subject><subject>Smoking cessation</subject><subject>Smoking Cessation - methods</subject><subject>Smoking Cessation - psychology</subject><subject>Smoking Water Pipes</subject><subject>Study Protocol</subject><subject>Time Factors</subject><subject>Tobacco</subject><subject>Tobacco Use Cessation Devices - adverse effects</subject><subject>Tobacco, Waterpipe - adverse effects</subject><subject>Treatment Outcome</subject><subject>Varenicline</subject><subject>Varenicline - adverse effects</subject><subject>Varenicline - therapeutic use</subject><subject>Water pipes</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptUk1rFTEUHUSxtfoD3EjA9dR8TJKZjVCKtkLBTV2HJHPzXupMMiZ5T8Yf4O82j1drCyaLXM6953ByOU3zluBzQnrxIROGBWsxES2RgrTrs-aUyI63ghL-_FF90rzK-Q7jjg2se9mc0B5LSQQ7bX7fbgGBc95qu6Lo0F4nCN5OPgDyAWm79bD3YYO0yaWCwQLSc6zAT10gLX4BVKLR1kaU5_gdUkYtymU3rmhJsUQbJ-RiQholHcY4-18wIhtDSXGaalmS19Pr5oXTU4Y39-9Z8-3zp9vL6_bm69WXy4ub1nZDV1qQBouOi95QOsjBsAFzN1JpNLbccu0cFuCoMwYz6NnYE87JQCkbqOFOD-ys-XjUXXZmhtFCtaEntSQ_67SqqL162gl-qzZxrzilvJ4q8P5eIMUfO8hF3cVdCtWzonLgVAgp2b-pjZ5A-eBiFbOzz1ZddFJSwhg9mDn_z1S9I8y-bgicr_gTAjkSbIo5J3APxglWh0SoYyJUTYQ6JEKtlfPu8Y8fGH8jwP4AeWmzxA</recordid><startdate>20170111</startdate><enddate>20170111</enddate><creator>Zahid, Raana</creator><creator>Dogar, Omara</creator><creator>Mansoor, Sonia</creator><creator>Khan, Amina</creator><creator>Kanaan, Mona</creator><creator>Jawad, Mohammed</creator><creator>Ahluwalia, Jasjit S</creator><creator>Siddiqi, Kamran</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20170111</creationdate><title>The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial</title><author>Zahid, Raana ; Dogar, Omara ; Mansoor, Sonia ; Khan, Amina ; Kanaan, Mona ; Jawad, Mohammed ; Ahluwalia, Jasjit S ; Siddiqi, Kamran</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-e7b064568b22979b3905fd27ba0c5c5aff06ef2fbb03e83d81551922392b5fa93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Abstinence</topic><topic>Adults</topic><topic>Affect - drug effects</topic><topic>Behavior Therapy - methods</topic><topic>Cigarettes</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Combined Modality Therapy</topic><topic>Consent</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Health aspects</topic><topic>Hookahs</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Methods</topic><topic>Nicotine</topic><topic>Nicotinic Agonists - adverse effects</topic><topic>Nicotinic Agonists - therapeutic use</topic><topic>Pakistan</topic><topic>Patient outcomes</topic><topic>Public health</topic><topic>Recurrence</topic><topic>Research Design</topic><topic>Smokers - psychology</topic><topic>Smoking cessation</topic><topic>Smoking Cessation - methods</topic><topic>Smoking Cessation - psychology</topic><topic>Smoking Water Pipes</topic><topic>Study Protocol</topic><topic>Time Factors</topic><topic>Tobacco</topic><topic>Tobacco Use Cessation Devices - adverse effects</topic><topic>Tobacco, Waterpipe - adverse effects</topic><topic>Treatment Outcome</topic><topic>Varenicline</topic><topic>Varenicline - adverse effects</topic><topic>Varenicline - therapeutic use</topic><topic>Water pipes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zahid, Raana</creatorcontrib><creatorcontrib>Dogar, Omara</creatorcontrib><creatorcontrib>Mansoor, Sonia</creatorcontrib><creatorcontrib>Khan, Amina</creatorcontrib><creatorcontrib>Kanaan, Mona</creatorcontrib><creatorcontrib>Jawad, Mohammed</creatorcontrib><creatorcontrib>Ahluwalia, Jasjit S</creatorcontrib><creatorcontrib>Siddiqi, Kamran</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zahid, Raana</au><au>Dogar, Omara</au><au>Mansoor, Sonia</au><au>Khan, Amina</au><au>Kanaan, Mona</au><au>Jawad, Mohammed</au><au>Ahluwalia, Jasjit S</au><au>Siddiqi, Kamran</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2017-01-11</date><risdate>2017</risdate><volume>18</volume><issue>1</issue><spage>14</spage><pages>14-</pages><artnum>14</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers.
This is a two-arm, double-blind, placebo-controlled randomized trial conducted in four districts in Punjab, Pakistan. Study participants include adults using a waterpipe (with or without concomitant cigarette, bidi or other forms of tobacco smoking) on a daily basis for at least 6 months and who are willing to quit. We will individually randomize 510 participants to one of the two arms of the trial. Participants in the intervention arm will receive varenicline and behavioral support and those in the control arm will receive placebo and behavioral support. The primary outcome will be continuous abstinence for at least 6 months (week 25) which is biochemically verified by a carbon monoxide level of <10 ppm. Secondary outcomes will include biochemically verified 7-day point abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment points. Tertiary outcomes will include assessment of withdrawal symptoms using the Mood and Physical Symptoms Scale (MPSS), smoking dependency using the Lebanon Waterpipe Dependency Scale (LWDS-11) and monitoring adverse outcomes.
This is an efficacy trial and would require a subsequent effectiveness trial for a definitive evaluation of the intervention.
ISRCTN, ISRCTN94103375 . Registered on 1 December 2015.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>28077163</pmid><doi>10.1186/s13063-016-1761-y</doi><oa>free_for_read</oa></addata></record> |
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| ispartof | Current controlled trials in cardiovascular medicine, 2017-01, Vol.18 (1), p.14, Article 14 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; SpringerLink Journals; PubMed Central; PubMed Central Open Access; Springer Nature OA Free Journals |
| subjects | Abstinence Adults Affect - drug effects Behavior Therapy - methods Cigarettes Clinical Protocols Clinical trials Combined Modality Therapy Consent Double-Blind Method Drug therapy Health aspects Hookahs Hospitals Humans Methods Nicotine Nicotinic Agonists - adverse effects Nicotinic Agonists - therapeutic use Pakistan Patient outcomes Public health Recurrence Research Design Smokers - psychology Smoking cessation Smoking Cessation - methods Smoking Cessation - psychology Smoking Water Pipes Study Protocol Time Factors Tobacco Tobacco Use Cessation Devices - adverse effects Tobacco, Waterpipe - adverse effects Treatment Outcome Varenicline Varenicline - adverse effects Varenicline - therapeutic use Water pipes |
| title | The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers - study protocol for a randomized controlled trial |
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