- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01023659
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their population level impact is limited by a combination of factors. Both bupropion and varenicline are only available through prescription, however smoking cessation clinics are few in number and only about 25% of smokers receive information on smoking cessation aids from their healthcare provider. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy in many jurisdictions, including Ontario. However, bupropion and varenicline have the potential to make a greater impact given their superior results from the clinical trials. Bupropion and varenicline present a unique challenge as they are prescribed medications, therefore we have proposed a variant of the mass distribution method to test whether it is practical to distribute them to a large number of people over a expansive geographic area (i.e., Ontario).
We hypothesize that engaging smokers with the opportunity to receive free bupropion or varenicline, to initiate an appointment with their physician to obtain a prescription that would be filled and mailed to the smoker from a central pharmacy would be a logistically feasible approach to reach high number of smokers from a wide geographic area. Our second hypothesis is that consistent with the results from clinical studies, in the general population varenicline would be associated with a higher abstinence rate than bupropion, and both varenicline and bupropion groups would achieve higher abstinence rates than those making quit attempts without any pharmacotherapy aid.
This is an open label, proof-of-concept study, wherein 2000 eligible participants will have the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Eligible participants will discuss with their doctor which of the two medications is appropriate for them to use as smoking cessation aid. It is also possible that the participant and his/her doctor may decide not to pursue smoking cessation using either of these medications. These participants will form a third intervention group, receiving only the weekly motivational emails. All participants will set a quit date of their choosing, but those receiving medication will set a quit date 7 days after starting the medication. The participants will enroll in the study via the study's website, at which time they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months after the end of treatment.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 1P7
- Centre for Addiction and Mental Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.
Exclusion Criteria:
- history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Bupropion + motivational emails
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
|
bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
Andre navn:
brief motivational emails, sent weekly for 12 weeks
|
Aktiv komparator: Varenicline + motivational emails
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
|
brief motivational emails, sent weekly for 12 weeks
varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
Andre navn:
|
Aktiv komparator: Motivational emails
participants receive weekly motivational emails for 12 weeks.
|
brief motivational emails, sent weekly for 12 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
7-day Point Prevalence of Abstinence
Tidsramme: 6-month
|
7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
|
6-month
|
Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
Tidsramme: End of Treatment
|
Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed
|
End of Treatment
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Kjemisk-induserte lidelser
- Stoffrelaterte lidelser
- Tobakksbruksforstyrrelse
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhemmere
- Psykotropiske stoffer
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhemmere
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, andre generasjon
- Cytokrom P-450 CYP2D6-hemmere
- Dopaminopptakshemmere
- Bupropion
- Vareniklin
Andre studie-ID-numre
- 068/2009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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