- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02896400
Optimizing Tobacco Dependence Treatment in the Emergency Department
Przegląd badań
Status
Szczegółowy opis
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
Our associated hypotheses are:
- At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
- At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
- At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Connecticut
-
New Haven, Connecticut, Stany Zjednoczone, 06519
- Yale School of Medicine
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
Exclusion Criteria:
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Eksperymentalny: BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
Eksperymentalny: BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
|
Brief motivational interview on smoking behavior
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Eksperymentalny: BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
|
Brief motivational interview on smoking behavior
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: BNI only
Brief Negotiated Interview (BNI)
|
Brief motivational interview on smoking behavior
|
Eksperymentalny: NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Eksperymentalny: NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
|
6 weeks of nicotine replacement, patches and gum.
First dose of each started in ED.
Patches are 14mg or 21 mg.
Gum is 2mg per piece.
|
Eksperymentalny: QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Eksperymentalny: QL only
Referral to CT Smokers Quitline (QL)
|
Faxed referral to the CT Smokers Quitline for the subject.
QL will then call subject to offer phone based counseling.
|
Eksperymentalny: Text only
Registration in SmokefreeText (Text)
|
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Brak interwencji: Control
Control arm, no intervention
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Tobacco Abstinence
Ramy czasowe: 3 months
|
Abstinence self reported and verified by exhaled carbon monoxide
|
3 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia wywołane chemicznie
- Procesy patologiczne
- Zaburzenia związane z substancjami
- Atrybuty choroby
- Sytuacje awaryjne
- Zaburzenia związane z używaniem tytoniu
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenci autonomiczni
- Agenty obwodowego układu nerwowego
- Środki cholinergiczne
- Stymulatory ganglionowe
- Agoniści nikotynowi
- Agoniści cholinergiczni
- Nikotyna
Inne numery identyfikacyjne badania
- 1603017332
- 1R01CA201873-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Zaburzenia związane z używaniem tytoniu
-
Assistance Publique - Hôpitaux de ParisMission Interministérielle de Lutte contre les Drogues et les Conduites Addictives... i inni współpracownicyZakończonyKonsumpcja substancji psychoaktywnych | Zaburzenie związane z substancjami | Off Label-use | Wzmocnienie funkcji poznawczychFrancja
-
Jagannadha R AvasaralaZakończonyStwardnienie rozsiane | Zapalenie nerwu wzrokowego | Neuromyelitis Optica Spectrum Disorder Atak | Zapalenie nerwu wzrokowego i spektrum zaburzeń nerwu wzrokowego Nawrót | Neuromyelitis Optica Spectrum Disorder ProgresjaStany Zjednoczone
-
Experimental and Clinical Research Center, a cooperation...RekrutacyjnyStwardnienie rozsiane | Choroby demielinizacyjne | Zapalenie nerwu wzrokowego | Neuromyelitis Optica Spectrum Disorder Atak | Choroba związana z przeciwciałami glikoproteinowymi mieliny oligodendrocytówWłochy, Stany Zjednoczone, Argentyna, Australia, Botswana, Brazylia, Kolumbia, Dania, Francja, Niemcy, Indie, Izrael, Japonia, Republika Korei, Hiszpania, Zjednoczone Królestwo, Zambia