- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01501877
Smoking Cessation Intervention for Diabetic Patients (SSTOP)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Individuals with Type 2 diabetes smoke at rates similar to those found in the general population, and the health consequences of smoking are particularly severe among smokers with diabetes. In fact, there appears to be a synergistic effect between smoking and diabetes on mortality. However, despite reports that highlight the importance of this work, a paucity of studies have been conducted to develop and test smoking cessation interventions tailored to meet the needs of individuals with diabetes. The small number of extant studies have yielded mixed results. Distress tolerance (DT) focused, acceptance-based interventions have demonstrated efficacy for smoking cessation, and there is increasing support for the conceptual model underlying these interventions among individuals with diabetes. The long-term objective of this research program is to improve smoking cessation treatment for individuals with Type 2 diabetes by developing and establishing the efficacy of a DT smoking cessation intervention tailored to this population. Furthermore, we seek to advance knowledge of the relationships among nicotine withdrawal, negative affect, distress tolerance, and smoking cessation outcomes among individuals with diabetes.
In the present study, we will develop a DT intervention tailored to meet the needs of smokers with Type 2 diabetes. In the first phase of this project, we will develop and pilot the intervention with 18 patients. In the second phase of the project, we will conduct a preliminary, randomized trial with 54 patients to examine the efficacy of the DT intervention relative to a standard smoking cessation treatment (ST) that equates for therapist contact time. Patients in both conditions will receive the transdermal nicotine patch.
We expect that, relative to the ST condition, patients randomized to the DT condition will have increased likelihood of smoking abstinence and increased latency to both smoking lapse and relapse. If the efficacy of this intervention can be established in this trial and in subsequent large scale randomized controlled trials, smokers with diabetes will have improved smoking cessation treatment options. The need for this work is great given the paucity of extant work in this area, the significantly heightened risk of morbidity and mortality from smoking among diabetic patients, the rapidly increasing rate of diabetes in the U.S., and an apparent stabilization of the smoking rate in recent years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 21 years of age or older
- Type 2 diabetes
- regular smoker for at least 3 years
- smoke an average of more than 10 cigarettes per day
- report motivation to quit smoking of at least 5 out of 10
- speak English
Exclusion Criteria:
- current alcohol abuse or dependence
- current substance abuse or dependence (excluding nicotine)
- psychotic
- form of diabetes other than Type 2
- medical condition that is a contraindication for the transdermal nicotine patch
- using pharmacotherapy for smoking cessation
- using other tobacco products
- unable to provide names and contact information for locators
- no access to a telephone
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Distress Tolerance
Acceptance and Commitment Therapy based Distress Tolerance (DT) smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
|
The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
|
Aktiv komparator: Standard Smoking Cessation
Standard smoking cessation intervention delivered in 7 2-hour group, 1 50-minute individual, and 2 10-minute phone sessions and 8 weeks of transdermal nicotine patch.
|
Standard smoking cessation intervention based on clinical practice guidelines.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Point prevalence abstinence from smoking
Tidsramme: 26 weeks from smoking quit date
|
We will compare the percentage of participants in each treatment condition who report abstinence from smoking for the 7 days preceding the assessment.
|
26 weeks from smoking quit date
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Susan E. Ramsey, Ph.D., Rhode Island Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DA030532
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 .
Kliniske forsøg med Acceptance and Commitment Therapy
-
King's College Hospital NHS TrustKing's College London; Barts & The London NHS Trust; University Hospital... og andre samarbejdspartnereAfsluttet
-
Duke UniversityAktiv, ikke rekrutterendeHæmatopoietisk dampcelletransplantation (HCT)Forenede Stater
-
National Cancer Institute (NCI)AfsluttetNeurofibromatose type 1 | Plexiforme neurofibromerForenede Stater
-
Southern Methodist UniversityAfsluttetAngst | Ikke-suicidal selvskadeForenede Stater
-
King's College LondonDiabetes UKUkendtDiabetes mellitus | Smertefuld diabetisk neuropatiDet Forenede Kongerige
-
Rikard WicksellRegion Stockholm; Skandia Insurance Company, Ltd.Afsluttet
-
Women's College HospitalIkke rekrutterer endnuPræmenstruel dysforisk lidelse | Præmenstruel forværring af humørforstyrrelser
-
University of CoimbraUkendtKronisk smertePortugal
-
Children's Mercy Hospital Kansas CityAktiv, ikke rekrutterendePædiatrisk ernæringsforstyrrelse, kronisk | Pædiatrisk fodringsdysfunktion, akutForenede Stater
-
The Miriam HospitalAktiv, ikke rekrutterendeOvervægt og fedmeForenede Stater