Back to resultsSubstance Use Disorders and Tobacco Habits
Primary Purpose
Substance Use Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
No smoking
Smoking
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use Disorders focused on measuring Tobacco use, withdrawal symptoms
Eligibility Criteria
Inclusion Criteria: Substance use disorder -
Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
-
Sites / Locations
- Uppsala University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
No smoking
Smoking
Arm Description
The ward where the patients can not go out to smoke
The ward where the patients can go out to smoke.
Outcomes
Primary Outcome Measures
Less smoking
Number of cigarettes /day
Less smoking
Number of cigarettes /day
Secondary Outcome Measures
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
Thought about not smoking any more
Questions
Thought about not smoking any more
Questions
Thought about not smoking any more
Questions
PEF
Improved expiratory flow
PEF
Improved expiratory flow
PEF
Improved expiratory flow
Weight
Changes in weight
Weight
Changes in weight
Weight
Changes in weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03118011
Brief Title
Substance Use Disorders and Tobacco Habits
Official Title
Tobacco Habits and the Ability to Quit Smoking Among Patients With Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Tobacco use, withdrawal symptoms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No smoking
Arm Type
Active Comparator
Arm Description
The ward where the patients can not go out to smoke
Arm Title
Smoking
Arm Type
Placebo Comparator
Arm Description
The ward where the patients can go out to smoke.
Intervention Type
Other
Intervention Name(s)
No smoking
Intervention Description
No smoking
Intervention Type
Other
Intervention Name(s)
Smoking
Intervention Description
Ability to go out to smoke
Primary Outcome Measure Information:
Title
Less smoking
Description
Number of cigarettes /day
Time Frame
From baseline to 1 month
Title
Less smoking
Description
Number of cigarettes /day
Time Frame
From baseline to 6 month
Secondary Outcome Measure Information:
Title
withdrawal symptoms
Description
Blood pressure, Worry, nausea e.t.c.
Time Frame
From baseline to emitted from the ward aproximately 1 week
Title
withdrawal symptoms
Description
Blood pressure, Worry, nausea e.t.c.
Time Frame
From baseline to 1 month
Title
withdrawal symptoms
Description
Blood pressure, Worry, nausea e.t.c.
Time Frame
From baseline to 6 month
Title
Thought about not smoking any more
Description
Questions
Time Frame
From baseline to emitted from the ward aproximately 1 week
Title
Thought about not smoking any more
Description
Questions
Time Frame
From baseline to 1 month
Title
Thought about not smoking any more
Description
Questions
Time Frame
From baseline to 6 month
Title
PEF
Description
Improved expiratory flow
Time Frame
From baseline to emitted from the ward aproximately 1 week
Title
PEF
Description
Improved expiratory flow
Time Frame
From baseline too 1 month
Title
PEF
Description
Improved expiratory flow
Time Frame
From baseline to 6 month
Title
Weight
Description
Changes in weight
Time Frame
From baseline to emitted from the ward aproximately 1 week
Title
Weight
Description
Changes in weight
Time Frame
From baseline to 1 month
Title
Weight
Description
Changes in weight
Time Frame
From baseline to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Substance use disorder -
Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Danielsson, MD, PhD
Phone
0046186112173
Email
katarina.danielsson@akademiska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina Danielsson, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarja-Leena Kirvesniemi
Phone
0046186110000
Email
katarina.danielsson@akademiska.se
First Name & Middle Initial & Last Name & Degree
tarja-leena.kirvesniemi@akademiska.se
First Name & Middle Initial & Last Name & Degree
Katarina Danielsson
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Substance Use Disorders and Tobacco Habits
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