- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03118011
Substance Use Disorders and Tobacco Habits
Tobacco Habits and the Ability to Quit Smoking Among Patients With Substance Use Disorders
In the department for substance use disorders at Uppsala University Hospital there are two wards. One that is locked, where the patients that are emitted can not go out to smoke and another ward where there is a possibility to go out and smoke during the day.
The smoking habits on those two floors will be compared and how they feel about smoking will be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6 months.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In the department for substance use disorders at Uppsala University Hospital there are two wards. One that is locked, where the patients that are emitted can not go out to smoke and another ward where there is a possibility to go out and smoke during the day.
The smoking habits on those two wards will be compared and how they feel about smoking will be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6 months.
The questionnaires that will be used for evaluation are:
Fagerstöms test for nicotine dependence, Alcohol Use Disorders Identification Test and Drug Use Disorders Identification Test and the symptoms of Tobacco withdrawal mentioned in DSM-V.
Parameters that will be measured are: pulse, bloodpressure, peak expiratory flow, wight and height.
There will also be some questions about their smoking and snuff habits, if they have tried to quite smoking Before and how they were affected by the stop.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Uppsala, Sverige
- Rekruttering
- Uppsala University Hospital
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Ta kontakt med:
- Tarja-Leena Kirvesniemi
- Telefonnummer: 0046186110000
- E-post: katarina.danielsson@akademiska.se
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Ta kontakt med:
- tarja-leena.kirvesniemi@akademiska.se
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Hovedetterforsker:
- Katarina Danielsson
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria: Substance use disorder -
Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: No smoking
The ward where the patients can not go out to smoke
|
No smoking
|
Placebo komparator: Smoking
The ward where the patients can go out to smoke.
|
Ability to go out to smoke
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Less smoking
Tidsramme: From baseline to 1 month
|
Number of cigarettes /day
|
From baseline to 1 month
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Less smoking
Tidsramme: From baseline to 6 month
|
Number of cigarettes /day
|
From baseline to 6 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
withdrawal symptoms
Tidsramme: From baseline to emitted from the ward aproximately 1 week
|
Blood pressure, Worry, nausea e.t.c.
|
From baseline to emitted from the ward aproximately 1 week
|
withdrawal symptoms
Tidsramme: From baseline to 1 month
|
Blood pressure, Worry, nausea e.t.c.
|
From baseline to 1 month
|
withdrawal symptoms
Tidsramme: From baseline to 6 month
|
Blood pressure, Worry, nausea e.t.c.
|
From baseline to 6 month
|
Thought about not smoking any more
Tidsramme: From baseline to emitted from the ward aproximately 1 week
|
Questions
|
From baseline to emitted from the ward aproximately 1 week
|
Thought about not smoking any more
Tidsramme: From baseline to 1 month
|
Questions
|
From baseline to 1 month
|
Thought about not smoking any more
Tidsramme: From baseline to 6 month
|
Questions
|
From baseline to 6 month
|
PEF
Tidsramme: From baseline to emitted from the ward aproximately 1 week
|
Improved expiratory flow
|
From baseline to emitted from the ward aproximately 1 week
|
PEF
Tidsramme: From baseline too 1 month
|
Improved expiratory flow
|
From baseline too 1 month
|
PEF
Tidsramme: From baseline to 6 month
|
Improved expiratory flow
|
From baseline to 6 month
|
Weight
Tidsramme: From baseline to emitted from the ward aproximately 1 week
|
Changes in weight
|
From baseline to emitted from the ward aproximately 1 week
|
Weight
Tidsramme: From baseline to 1 month
|
Changes in weight
|
From baseline to 1 month
|
Weight
Tidsramme: From baseline to 6 month
|
Changes in weight
|
From baseline to 6 month
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Katarina Danielsson, MD, PhD, Uppsala University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2017/048
Plan for individuelle deltakerdata (IPD)
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