Evaluation of a Cognitive Behavioral Smoking Reduction Program

NCT ID: NCT02337400

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Cognitive behavioral smoking reduction program "Smoke_less"

Intervention Type BEHAVIORAL

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

Counseling Interview

15 minute counseling interview

Group Type ACTIVE_COMPARATOR

15 minute counseling interview

Intervention Type BEHAVIORAL

Waiting Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral smoking reduction program "Smoke_less"

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

Intervention Type BEHAVIORAL

15 minute counseling interview

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oliver Pogarell

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Psychiatry

Munich, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28616772 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eval_Smoke_less_LMU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smoking Cessation in Alcoholics
NCT00963482 COMPLETED NA
Group Counseling for Smoking Cessation
NCT00104481 COMPLETED PHASE1/PHASE2
Pain and Smoking Study
NCT02971137 COMPLETED NA
Early Tobacco Abstinence - 5
NCT00224965 TERMINATED PHASE1
Overcoming Nicotine Dependence to Enable Quitting
NCT05513872 RECRUITING PHASE1/PHASE2