- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02896400
Optimizing Tobacco Dependence Treatment in the Emergency Department
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06519
- Yale School of Medicine
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: BNI only
Brief Negotiated Interview (BNI)
|
Brief motivational interview on smoking behavior
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Sperimentale: Text only
Registration in SmokefreeText (Text)
|
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
Nessun intervento: Control
Control arm, no intervention
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Tobacco Abstinence
Lasso di tempo: 3 months
|
Abstinence self reported and verified by exhaled carbon monoxide
|
3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Processi patologici
- Disturbi Correlati a Sostanze
- Attributi della malattia
- Emergenze
- Disturbo da uso di tabacco
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti colinergici
- Stimolanti gangliari
- Agonisti nicotinici
- Agonisti colinergici
- Nicotina
Altri numeri di identificazione dello studio
- 1603017332
- 1R01CA201873-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
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