NCT03118011

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

April 10, 2017

Last Update Submit

April 12, 2017

Conditions

Keywords

Tobacco use, withdrawal symptoms

Outcome Measures

Primary Outcomes (2)

  • Less smoking

    Number of cigarettes /day

    From baseline to 1 month

  • Less smoking

    Number of cigarettes /day

    From baseline to 6 month

Secondary Outcomes (12)

  • withdrawal symptoms

    From baseline to emitted from the ward aproximately 1 week

  • withdrawal symptoms

    From baseline to 1 month

  • withdrawal symptoms

    From baseline to 6 month

  • Thought about not smoking any more

    From baseline to emitted from the ward aproximately 1 week

  • Thought about not smoking any more

    From baseline to 1 month

  • +7 more secondary outcomes

Study Arms (2)

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

No smoking

No smoking
SmokingOTHER

Ability to go out to smoke

Smoking

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersTobacco UseSubstance Withdrawal Syndrome

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Katarina Danielsson, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Danielsson, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Doctor of Philosphy (Faculty of Medicine)

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

April 10, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations