- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Uppsala, Sverige
- Rekrytering
- Uppsala University Hospital
-
Kontakt:
- Tarja-Leena Kirvesniemi
- Telefonnummer: 0046186110000
- E-post: katarina.danielsson@akademiska.se
-
Kontakt:
- tarja-leena.kirvesniemi@akademiska.se
-
Huvudutredare:
- Katarina Danielsson
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria: Substance use disorder -
Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: No smoking
The ward where the patients can not go out to smoke
|
No smoking
|
|
Placebo-jämförare: Smoking
The ward where the patients can go out to smoke.
|
Ability to go out to smoke
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Less smoking
Tidsram: From baseline to 1 month
|
Number of cigarettes /day
|
From baseline to 1 month
|
|
Less smoking
Tidsram: From baseline to 6 month
|
Number of cigarettes /day
|
From baseline to 6 month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
withdrawal symptoms
Tidsram: 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
Tidsram: From baseline to 1 month
|
Blood pressure, Worry, nausea e.t.c.
|
From baseline to 1 month
|
|
withdrawal symptoms
Tidsram: From baseline to 6 month
|
Blood pressure, Worry, nausea e.t.c.
|
From baseline to 6 month
|
|
Thought about not smoking any more
Tidsram: 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
Tidsram: From baseline to 1 month
|
Questions
|
From baseline to 1 month
|
|
Thought about not smoking any more
Tidsram: From baseline to 6 month
|
Questions
|
From baseline to 6 month
|
|
PEF
Tidsram: From baseline to emitted from the ward aproximately 1 week
|
Improved expiratory flow
|
From baseline to emitted from the ward aproximately 1 week
|
|
PEF
Tidsram: From baseline too 1 month
|
Improved expiratory flow
|
From baseline too 1 month
|
|
PEF
Tidsram: From baseline to 6 month
|
Improved expiratory flow
|
From baseline to 6 month
|
|
Weight
Tidsram: From baseline to emitted from the ward aproximately 1 week
|
Changes in weight
|
From baseline to emitted from the ward aproximately 1 week
|
|
Weight
Tidsram: From baseline to 1 month
|
Changes in weight
|
From baseline to 1 month
|
|
Weight
Tidsram: From baseline to 6 month
|
Changes in weight
|
From baseline to 6 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Katarina Danielsson, MD, PhD, Uppsala University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017/048
Plan för individuella deltagardata (IPD)
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