Substance Use Disorders and Tobacco Habits | NCT03118011

Studies
Substance Use Disorders and Tobacco Habits

NCT03118011

Sponsor

Uppsala University

Status

Unknown status

Last Update Posted

Apr 18, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Substance Use Disorders

Interventions

No smoking
Smoking

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2017Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 12, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2017

Last Update Posted Date

Apr 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katarina Danielsson, Medical Doctor, Doctor of Philosphy (Faculty of Medicine), Uppsala UniversityPrincipal Investigator

Lead Sponsor

Uppsala UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No smoking	Active Comparator	The ward where the patients can not go out to smoke	Other: No smoking
Smoking	Placebo Comparator	The ward where the patients can go out to smoke.	Other: Smoking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No smoking	Other	No smoking	No smoking
Smoking

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Substance use disorder -

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katarina Danielsson, MD, PhD	Contact	0046186112173		katarina.danielsson@akademiska.se

Overall Officials

Name	Affiliation	Role
Katarina Danielsson, MD, PhD	Uppsala University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Hospital	Recruiting	Uppsala	Uppsala County		Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D064424	Tobacco Use
D013375	Substance Withdrawal Syndrome

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074602	Smoking Devices

Ancestor Terms

ID	Term
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided