Tobacco ReductionNCT02337400
Evaluation of a Cognitive Behavioral Smoking Reduction Program
A study testing Cognitive behavioral smoking reduction program "Smoke_less" and 15 minute counseling interview in people with Tobacco Reduction, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less")… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Reduction
- What is being tested?
- Cognitive behavioral smoking reduction program "Smoke_less" and 15 minute counseling interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Apr 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years
- Result Fagerström-Test >= 3
- Consumption of at least 10 Cig./day
- carbon monoxide >= 8 ppm
- Wish, to reduce smoking but no intention to stop smoking within the next 4 weeks
- Agreement, to resign to nicotine replacement therapy, other therapies for smoking reduction, e-cigarettes or non-smoking tobacco products during study time
Who cannot join
- severe psychiatric disorder
- severe neurologic disease
- alcohol, drug or medication abuse (acute or in anamnesis)
- severe cardiovascular disease
- severe cancer disease
- severe internal disease
Show all 10Show fewer
- Consumption of psychopharmacological medication
- acute suicidal tendency
- pregnancy or lactation
- consumption of medication therapy for smoking reduction in the last 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten
The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting group: no intervention.
The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.
- Conditions
- Tobacco Reduction
- Being tested
- Cognitive behavioral smoking reduction program "Smoke_less", 15 minute counseling interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral smoking reduction program "Smoke_less"Behavioural
Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls
15 minute counseling interviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smoking Reduction Program | Experimental | Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls Receives: Behavioral: Cognitive behavioral smoking reduction program "Smoke_less" |
| Counseling Interview | Active comparator | 15 minute counseling interview Receives: Behavioral: 15 minute counseling interview |
| Waiting Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Secondary outcomes (9)
Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in stress scale at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks
Measured: 6, 17 and 29 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco ReductionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Pogarell, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337400
- Sponsor's protocol ID
- Eval_Smoke_less_LMU
- Status last verified
- Aug 2016
- First submitted
- 9 Jan 2015
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruther T, Kiss A, Eberhardt K, Linhardt A, Kroger C, Pogarell O. Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2018 Apr;268(3):269-277. doi: 10.1007/s00406-017-0818-6. Epub 2017 Jun 14.
PubMed 28616772
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Das Verhaltenstherapeutische Therapiemanual "Smoke_less" Zur Reduktion Des Tabakkonsums: Eine Evaluationsstudie Mit Ambulanten Patienten
- ClinicalTrials.gov ID
- NCT02337400
- Acronym / sponsor ID
- Eval_Smoke_less_LMU
- Conditions
- Tobacco Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for ambulant patients in a three-armed study design. Study participants will be randomized to one of the following three study groups: experimental group: 5-week lasting cognitive behavioral reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting group: no intervention.
The three follow-up measures take place after the reduction program in week 6, 17 an 29. After the finalisation of the last follow-up, participants from the active comparator and waiting group get the chance to take part at the smoking reduction program at no charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoking Reduction Program | Experimental | Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls |
| Counseling Interview | Active comparator | Behavioral: 15 minute counseling interview15 minute counseling interview |
| Waiting Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-70 years
- Result Fagerström-Test >= 3
- Consumption of at least 10 Cig./day
- carbon monoxide >= 8 ppm
- Wish, to reduce smoking but no intention to stop smoking within the next 4 weeks
Key exclusion criteria (10 listed)
- severe psychiatric disorder
- severe neurologic disease
- alcohol, drug or medication abuse (acute or in anamnesis)
- severe cardiovascular disease
- severe cancer disease
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 |
|---|---|---|
| Cognitive behavioral smoking reduction program "Smoke_less"Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls | Behavioural | Smoking Reduction Program |
| 15 minute counseling interview | Behavioural | Counseling Interview |
Primary outcome
Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
9 secondary outcomes
Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in stress scale at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks
Time frame: 6, 17 and 29 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 28616772Ruther T, Kiss A, Eberhardt K, Linhardt A, Kroger C, Pogarell O. Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2018 Apr;268(3):269-277. doi: 10.1007/s00406-017-0818-6. Epub 2017 Jun 14.
- Program and study description in germanLink provided by the sponsor.
Related trials for Tobacco Reduction
Recruiting
Interventional Study on Smoking Reduction in Psychiatry
Tobacco Addiction
Recruiting
Trauma-Informed Care for Smoking Cessation for Pregnancy
Smoking Cessation, Tobacco Smoking
RecruitingPhase 4
Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Veterans, Tobacco Use Disorder
Recruiting
A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home
Smoking, Smoking Cessation
Recruiting
Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
Nicotine Dependence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral smoking reduction program "Smoke_less" and 15 minute counseling interview in people with Tobacco Reduction, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 31 Aug 2016. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks (time frame: 6, 17 and 29 weeks). 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?
On the ClinicalTrials.gov record for NCT02337400, which also lists 1 linked publication.
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 31 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.