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A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
14 maart 2016 bijgewerkt door: Joel Erblich, Icahn School of Medicine at Mount Sinai
A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
This study has three main aims.
Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit).
Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm.
Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
Smoking remains an intransigent public health concern.
There is ample evidence that non-pharmacological factors, such as environmental triggers (e.g., sight or smell of a cigarette), can give rise to strong classically-conditioned urges to smoke (termed 'cue-reactivity' [CR]), and that exposure to smoking cues can contribute to cessation failure.
One promising intervention that may address CR is scheduled smoking with gradual reduction (SGR).
Under SGR, individuals smoke only at fixed intervals, and over several weeks, systematically decrease their cigarettes consumed each day.
The approach is postulated to: 1) provide 'practice' coping with environmentally-triggered cravings that occur during the inter-cigarette intervals, yielding increased self-efficacy to quit, and 2) weaken the associations between cues and smoking.
Accumulating evidence has also shown that the smoking cessation drug, varenicline (VN), substantially ameliorates cravings and enhances cessation, significantly outperforming other drugs.
Interestingly, recent animal research suggests that VN may operate at least partially by dampening conditioned drug cravings.
A combination therapy consisting of SGR+VN might thus lead to significantly enhanced cessation, simultaneously attacking cravings using both pharmacological and non-pharmacological approaches.
Because the beneficial effects of SGR and VN may be at least partially due to enhanced management of conditioned cravings, it is possible that that they will be particularly efficacious for smokers with high levels of CR.
Using both laboratory experimental techniques and a prospective intervention design in this R34 application, we propose to provide initial data to: 1) test the hypothesis that a combination of SGR+VN will enhance cessation, 2) explore the possibility that SGR and VN might be particularly efficacious among smokers with higher levels of CR, and 3) explore potential mechanisms underlying treatment effects.
Findings from this study would set the stage for larger efficacy and effectiveness trials of SGR alone and in conjunction with VN, as well as efforts to target SGR and/or VN toward the subgroups that would benefit the most (e.g., smokers with high levels of CR, carriers of specific smoking-related genotypes).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
32
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10029
- Icahn School of Medicine at Mount Sinai
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Current cigarette smoker
- Averages at least 10 cigarettes/day for 5 or more years
- DSM-IV diagnosis of Nicotine Dependence
- Breath carbon monoxide > 6 ppm
- Motivated to quit: score > 8 on Contemplation Ladder
- Age > 18 years
Exclusion Criteria:
- Current illicit substance use
- Other tobacco use (e.g., cigar, pipe)
- History of psychosis
- Past or current cardiovascular disease
- Impaired renal functioning
- Pregnancy
- Nursing
- Current treatment for smoking cessation
- Clinically significant depressive symptoms (CES-D > 16)
- Current suicidal ideation
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Scheduled Gradual Reduction + Varenicline
Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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Experimenteel: Scheduled Gradual Reduction + Placebo Drug
Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take placebo pills matching the schedule of the VN group.
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Experimenteel: Basic Advice + Varenicline
Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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Placebo-vergelijker: Basic Advice + Placebo Drug
Participants will be given basic advice along with a placebo drug matching the schedule of the VN group.
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take placebo pills matching the schedule of the VN group.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Comparison of Prolonged Abstinence
Tijdsspanne: up to12 weeks post-quit
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Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
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up to12 weeks post-quit
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Comparison of Continuous Abstinence
Tijdsspanne: 30 days post-quit and 30 days post end-of-treatment
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Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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Comparison of Survival
Tijdsspanne: 30 days post-quit and 30 days post end-of-treatment
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Survival as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joel Erblich, Ph.D, Icahn School of Medicine at Mount Sinai
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2012
Primaire voltooiing (Werkelijk)
1 januari 2014
Studie voltooiing (Werkelijk)
1 januari 2014
Studieregistratiedata
Eerst ingediend
17 januari 2013
Eerst ingediend dat voldeed aan de QC-criteria
18 januari 2013
Eerst geplaatst (Schatting)
21 januari 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
16 maart 2016
Laatste update ingediend die voldeed aan QC-criteria
14 maart 2016
Laatst geverifieerd
1 maart 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 10-0879
- 5R34DA031327-02 (Subsidie/contract van de Amerikaanse NIH)
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