Substance Use DisordersNCT03118011
Substance Use Disorders and Tobacco Habits
A study testing No smoking and Smoking in people with Substance Use Disorders, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- No smoking and Smoking
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 10 Apr 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County
Tarja-Leena Kirvesniemi, 0046186110000, katarina.danielsson@akademiska.se
tarja-leena.kirvesniemi@akademiska.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- No smoking, Smoking
- Keywords
- Tobacco use, withdrawal symptoms
- Medical subject headings
- Substance-Related Disorders, Tobacco Use, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No smokingOther
No smoking
SmokingOther
Ability to go out to smoke
| Study group | Role | What they receive |
|---|---|---|
| No smoking | Active comparator | The ward where the patients can not go out to smoke Receives: Other: No smoking |
| Smoking | Placebo comparator | The ward where the patients can go out to smoke. Receives: Other: Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less smoking
Number of cigarettes /day
Measured: From baseline to 1 month
Less smoking
Number of cigarettes /day
Measured: From baseline to 6 month
Secondary outcomes (12)
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
Measured: From baseline to emitted from the ward aproximately 1 week
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
Measured: From baseline to 1 month
withdrawal symptoms
Blood pressure, Worry, nausea e.t.c.
Measured: From baseline to 6 month
Thought about not smoking any more
Questions
Measured: From baseline to emitted from the ward aproximately 1 week
Thought about not smoking any more
Questions
Measured: From baseline to 1 month
Thought about not smoking any more
Questions
Measured: From baseline to 6 month
PEF
Improved expiratory flow
Measured: From baseline to emitted from the ward aproximately 1 week
PEF
Improved expiratory flow
Measured: From baseline too 1 month
PEF
Improved expiratory flow
Measured: From baseline to 6 month
Weight
Changes in weight
Measured: From baseline to emitted from the ward aproximately 1 week
Weight
Changes in weight
Measured: From baseline to 1 month
Weight
Changes in weight
Measured: From baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start10 Apr 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Danielsson, Uppsala University
- Investigators
- Katarina Danielsson, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118011
- Sponsor's protocol ID
- 2017/048
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Habits and the Ability to Quit Smoking Among Patients With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT03118011
- Acronym / sponsor ID
- 2017/048
- Conditions
- Substance Use Disorders
- Keywords
- Tobacco use, withdrawal symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No smoking | Active comparator | Other: No smokingThe ward where the patients can not go out to smoke |
| Smoking | Placebo comparator | Other: SmokingThe ward where the patients can go out to smoke. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No smokingNo smoking | Other | No smoking |
| SmokingAbility to go out to smoke | Other | Smoking |
Primary outcome
Less smoking
Time frame: From baseline to 1 month
Number of cigarettes /day
Less smoking
Time frame: From baseline to 6 month
Number of cigarettes /day
12 secondary outcomes
withdrawal symptoms
Time frame: From baseline to emitted from the ward aproximately 1 week
withdrawal symptoms
Time frame: From baseline to 1 month
withdrawal symptoms
Time frame: From baseline to 6 month
Thought about not smoking any more
Time frame: From baseline to emitted from the ward aproximately 1 week
Thought about not smoking any more
Time frame: From baseline to 1 month
Thought about not smoking any more
Time frame: From baseline to 6 month
PEF
Time frame: From baseline to emitted from the ward aproximately 1 week
PEF
Time frame: From baseline too 1 month
PEF
Time frame: From baseline to 6 month
Weight
Time frame: From baseline to emitted from the ward aproximately 1 week
Weight
Time frame: From baseline to 1 month
Weight
Time frame: From baseline to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Danielsson, MD, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No smoking and Smoking in people with Substance Use Disorders, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarina Danielsson, MD, PhD (0046186112173, katarina.danielsson@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Less smoking (time frame: From baseline to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.