Smoking Cessation for Smokers With Sleep Problems
20. december 2017 opdateret af: Yale University
This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation.
The study is designed to find out whether one of these counseling interventions is more effective for smoking cessation among individuals with sleep problems.
The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and 3) a 1-month follow-up.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a developmental study to: 1) create and test an integrated cognitive-behavioral smoking cessation and insomnia intervention with 30 smokers who report current insomnia.
Participants are randomized to 1 of 2 counseling conditions.
The cognitive-behavioral intervention provides standard care smoking counseling along with counseling to address insomnia.
The smoking counseling intervention provides standard care smoking counseling adapted from the American Lung Association Freedom from Smoking program.
Efficacy data from this trial will be used to determine effect size estimates for biologically confirmed self-reported point prevalence smoking abstinence at the end of treatment and 1 month after completing treatment.
Changes in sleep efficiency and self-control to resist smoking urges will also be examined.
If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale large study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Yale University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between the ages of 18 and 75.
- Smoking 10 or more cigarettes per day for at least 1 year.
- An expired air breath carbon monoxide level > 10 ppm.
- Motivated to stop smoking.
- Understand English.
- Meet DSM-IV criteria for insomnia.
- Report sleep latency or waking after sleep onset >30 minutes on ≥6 occasions within past month.
Exclusion Criteria:
- History of allergic reactions to adhesives.
- Unstable psychiatric/medical conditions such as current suicidal or homicidal ideation, acute psychosis, dementia.
- Have a current diagnosis of DSM-IV alcohol or drug dependence other than nicotine.
- Use of tobacco products other than cigarettes or use of marijuana.
- Intention to use nicotine replacement therapy, varenicline, or bupropion during study participation.
- Females of childbearing potential who are pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide).
- New onset of psychiatric disorders or new psychotropic medications within the past 3 months.
- Inability to read/understand English.
- History of sleep apnea based on responses to Berlin Questionnaire.
- History of restless leg syndrome.
- Current night or rotating shift work.
- Proposed travel across 2 or more time zones during study participation.
- Medical/psychiatric conditions contraindicated for sleep restriction (i.e., seizure disorders, severe excessive daytime sleepiness - Epworth Scale >18, and bipolar disorder).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Cognitive-Behavioral Counseling
The intervention consists of 8 sessions provided over 10 weeks.
Counseling commences 4 weeks before quitting smoking.
Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.
|
The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia.
Andre navne:
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Placebo komparator: Smoking Cessation Counseling
The intervention consists of 8 sessions provided over 10 weeks.
Counseling commences 4 weeks before quitting smoking.
Participants will also receive the nicotine patch for 6 weeks starting on the day of quit date.
|
The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Smoking Abstinence
Tidsramme: 1 Week
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Smoking abstinence is operationally defined as "no smoking on the last 7 days of the last week of treatment.
And no smoking within the last 7 days at the first follow-up visit 4 weeks after completing treatment."
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1 Week
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-Control to Resist Smoking Cues
Tidsramme: 4 Weeks
|
To develop an effect size estimate for changes in self-control to resist smoking cues from baseline to the day before quitting smoking comparing smokers in the two counseling conditions.
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4 Weeks
|
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Sleep Efficiency
Tidsramme: Change from Baseline at 4 weeks
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Self-reported sleep efficiency subscale of the Pittsburgh Sleep Quality Index.
This is calculated as the percentage of total time spent asleep in a night compared to the total time spent in bed, multiplied by 100.
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Change from Baseline at 4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa Fucito, PhD, Yale University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Faktiske)
1. marts 2012
Studieafslutning (Faktiske)
1. marts 2012
Datoer for studieregistrering
Først indsendt
13. januar 2011
Først indsendt, der opfyldte QC-kriterier
13. januar 2011
Først opslået (Skøn)
17. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2017
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1005006857
- P50DA009241-16 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .