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Substance Use Disorders and Tobacco Habits

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ClinicalTrials.gov Identifier: NCT03118011
Recruitment Status : Unknown
Verified April 2017 by Katarina Danielsson, Uppsala University.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Katarina Danielsson, Uppsala University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Substance Use Disorders Other: No smoking Other: Smoking Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tobacco Habits and the Ability to Quit Smoking Among Patients With Substance Use Disorders
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: No smoking
The ward where the patients can not go out to smoke
 Other: No smoking
No smoking
Placebo Comparator: Smoking
The ward where the patients can go out to smoke.
 Other: Smoking
Ability to go out to smoke


Outcome Measures
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Primary Outcome Measures :
  1. Less smoking [ Time Frame: From baseline to 1 month ]
    Number of cigarettes /day

  2. Less smoking [ Time Frame: From baseline to 6 month ]
    Number of cigarettes /day


Secondary Outcome Measures :
  1. withdrawal symptoms [ Time Frame: From baseline to emitted from the ward aproximately 1 week ]
    Blood pressure, Worry, nausea e.t.c.

  2. withdrawal symptoms [ Time Frame: From baseline to 1 month ]
    Blood pressure, Worry, nausea e.t.c.

  3. withdrawal symptoms [ Time Frame: From baseline to 6 month ]
    Blood pressure, Worry, nausea e.t.c.

  4. Thought about not smoking any more [ Time Frame: From baseline to emitted from the ward aproximately 1 week ]
    Questions

  5. Thought about not smoking any more [ Time Frame: From baseline to 1 month ]
    Questions

  6. Thought about not smoking any more [ Time Frame: From baseline to 6 month ]
    Questions

  7. PEF [ Time Frame: From baseline to emitted from the ward aproximately 1 week ]
    Improved expiratory flow

  8. PEF [ Time Frame: From baseline too 1 month ]
    Improved expiratory flow

  9. PEF [ Time Frame: From baseline to 6 month ]
    Improved expiratory flow

  10. Weight [ Time Frame: From baseline to emitted from the ward aproximately 1 week ]
    Changes in weight

  11. Weight [ Time Frame: From baseline to 1 month ]
    Changes in weight

  12. Weight [ Time Frame: From baseline to 6 month ]
    Changes in weight


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Substance use disorder -

Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118011


Contacts
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Contact: Katarina Danielsson, MD, PhD 0046186112173 katarina.danielsson@akademiska.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Tarja-Leena Kirvesniemi    0046186110000    katarina.danielsson@akademiska.se   
Contact: tarja-leena.kirvesniemi@akademiska.se         
Principal Investigator: Katarina Danielsson         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Katarina Danielsson, MD, PhD Uppsala University Hospital
More Information
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Responsible Party: Katarina Danielsson, Medical Doctor, Doctor of Philosphy (Faculty of Medicine), Uppsala University
ClinicalTrials.gov Identifier: NCT03118011    
Other Study ID Numbers: 2017/048
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katarina Danielsson, Uppsala University:
Tobacco use, withdrawal symptoms
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders