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CompletedNCT02337400Updated Aug 31, 2016

Evaluation of a Cognitive Behavioral Smoking Reduction Program

An interventional study of Cognitive behavioral smoking reduction program "Smoke_less" and 15 minute counseling interview in Tobacco Reduction, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-31.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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"); 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.

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Conditions studied

  • Tobacco Reduction
03

In context

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • severe psychiatric disorder
  • severe neurologic disease
  • alcohol, drug or medication abuse (acute or in anamnesis)
  • severe cardiovascular disease
  • severe cancer disease
  • severe internal disease
  • Consumption of psychopharmacological medication
  • acute suicidal tendency
  • pregnancy or lactation
  • consumption of medication therapy for smoking reduction in the last 3 month
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    Smoking Reduction Program

    Cognitive behavioral smoking reduction program "Smoke_less" Duration: 5 weeks with 4 weekly sessions over 2,5 hours and two phone calls

    Behavioral: Cognitive behavioral smoking reduction program "Smoke_less"

  • Active comparator
    Counseling Interview

    15 minute counseling interview

    Behavioral: 15 minute counseling interview

  • No intervention
    Waiting Control Group

Interventions

  • BehavioralCognitive behavioral smoking reduction program "Smoke_less"

    Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls

  • Behavioral15 minute counseling interview
06

What researchers measure

Primary outcomes

  1. Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  2. Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

Secondary outcomes

  1. Change from baseline in Fagerström Test for Nicotine Dependence at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  2. Change from baseline in Questionnaire of Smoking Urges at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  3. Change from baseline in Readiness to Change Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  4. Change from baseline in Process of Change Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  5. Change from baseline in Decisional Balance Questionnaire at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  6. Change from baseline in Self-Efficacy scale for smokers 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  7. Change from baseline in knowledge and skills scale about smoking reduction at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  8. Change from baseline in stress scale at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

  9. Change from baseline in health satisfaction satisfaction scale at 6, 17 and 29 weeks

    Time frame: 6, 17 and 29 weeks

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Study locations

1 site
  • Dept. of Psychiatry
    Munich, D-80336, Germany
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02337400
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
Oliver Pogarell (Prof. Dr. med., Ludwig-Maximilians - University of Munich) — Principal investigator
First posted
Jan 13, 2015
Start date
Jan 2015
Primary completion
Feb 2016
Completion
Apr 2016
Last update
Aug 31, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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