Evaluation of Learning-Theory-Based Smoking Cessation Strategies
30. mars 2022 oppdatert av: Danielle E. McCarthy, Ph.D., Rutgers University
This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling.
The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking.
This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Participants in this study are randomized to one of two treatments conditions prior to a target quit date.
- One-half of participants will be randomly assigned to receive standard smoking cessation treatment comprising a 6-week supply of 21-mg nicotine patches and 4 individual smoking cessation counseling sessions.
- The other one-half of participants will be randomly assigned to receive standard treatment (patch and counseling, as above) plus to practice quitting 7 times over the 2.5 weeks leading up to a quit attempt. Practice quitting will involve not smoking for a period of time tailored to each individual's smoking pattern.
- All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls.
- All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones.
- Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews.
- All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person).
Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview.
- One-half of people eligible for this phase of the study will be randomly assigned to receive a supply of non-nicotine cigarettes to smoke for up to 6 weeks. The non-nicotine cigarettes are designed to help break the habit of smoking and to help smokers return to being smoke-free after smoking regular cigarettes.
- The other one-half of eligible smokers will be randomly assigned to not receive these non-nicotine cigarettes.
- All smokers eligible for this phase of the study will be asked to complete cellular telephone reports about their mood, thoughts, and behaviors for 14 days beginning 4.5 weeks after a target stop-smoking date. Compensation will be provided for completing these cellular telephone phone reports.
Studietype
Intervensjonell
Registrering (Faktiske)
93
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New Jersey
-
New Brunswick, New Jersey, Forente stater, 08901
- Rutgers University Institute for Health, Health Care Policy, and Aging Research
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Smoke cigarettes daily
- Motivated to quit smoking
- Able to read and write English
- Willing and able to complete study visits and cell phone calls
Exclusion Criteria:
- Pregnancy, breastfeeding, planning on becoming pregnant during the study
- Recent heart attack or heart surgery, heart disease, unstable angina
- Allergy to adhesives
- Past negative reactions to nicotine patch
- Serious skin conditions
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard treatment
In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
|
Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
Andre navn:
|
|
Eksperimentell: Standard treatment+practice quitting
In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
|
This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
Andre navn:
|
|
Eksperimentell: Very low nicotine cigarettes
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group.
Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine.
This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
|
This intervention will be offered to a subset of smokers from both of the other study arms.
To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above.
Tobacco cigarettes containing very low levels of nicotine (.016-.019
mg in smoke from the cigarettes).
These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
|
|
Ingen inngripen: Advice and encouragement only
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition.
Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
4-week Abstinence
Tidsramme: 4 weeks
|
7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
10-week Abstinence
Tidsramme: 10 weeks
|
This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.
|
10 weeks
|
|
Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
Tidsramme: 3 weeks pre-quit
|
Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment.
These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior.
Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident.
|
3 weeks pre-quit
|
|
Prolonged Abstinence
Tidsramme: 10 weeks
|
This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.
|
10 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Danielle E McCarthy, Ph.D., Rutgers 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. juni 2012
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
6. juni 2011
Først innsendt som oppfylte QC-kriteriene
6. juni 2011
Først lagt ut (Anslag)
8. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. mars 2022
Sist bekreftet
1. mars 2022
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
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Ganglioniske stimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Nikotin
Andre studie-ID-numre
- DA026511
- 1R21DA026511-01A1 (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. .