Smoking Cessation for Smokers With Sleep Problems
20. desember 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06511
- Yale University School Of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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 navn:
|
|
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking Abstinence
Tidsramme: 1 Week
|
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."
|
1 Week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
4 Weeks
|
|
Sleep Efficiency
Tidsramme: Change from Baseline at 4 weeks
|
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.
|
Change from Baseline at 4 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa Fucito, PhD, Yale University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2010
Primær fullføring (Faktiske)
1. mars 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
13. januar 2011
Først innsendt som oppfylte QC-kriteriene
13. januar 2011
Først lagt ut (Anslag)
17. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. desember 2017
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1005006857
- P50DA009241-16 (U.S. NIH-stipend/kontrakt)
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. .