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.

Study Overview

• Status: Unknown
• Conditions: Substance Use Disorders
• Intervention / Treatment: Other: No smoking; Other: Smoking

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Recruiting
    • Uppsala University Hospital
    • Contact: Tarja-Leena Kirvesniemi; Phone Number: 0046186110000; Email: katarina.danielsson@akademiska.se
    • Contact: tarja-leena.kirvesniemi@akademiska.se
    • Principal Investigator: Katarina Danielsson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Substance use disorder -

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Less smoking	Number of cigarettes /day	From baseline to 1 month
Less smoking	Number of cigarettes /day	From baseline to 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
withdrawal symptoms	Blood pressure, Worry, nausea e.t.c.	From baseline to emitted from the ward aproximately 1 week
withdrawal symptoms	Blood pressure, Worry, nausea e.t.c.	From baseline to 1 month
withdrawal symptoms	Blood pressure, Worry, nausea e.t.c.	From baseline to 6 month
Thought about not smoking any more	Questions	From baseline to emitted from the ward aproximately 1 week
Thought about not smoking any more	Questions	From baseline to 1 month
Thought about not smoking any more	Questions	From baseline to 6 month
PEF	Improved expiratory flow	From baseline to emitted from the ward aproximately 1 week
PEF	Improved expiratory flow	From baseline too 1 month
PEF	Improved expiratory flow	From baseline to 6 month
Weight	Changes in weight	From baseline to emitted from the ward aproximately 1 week
Weight	Changes in weight	From baseline to 1 month
Weight	Changes in weight	From baseline to 6 month

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Katarina Danielsson, MD, PhD, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Tobacco use, withdrawal symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2017/048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No