NCT00963482

Brief Summary

Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate whether a specific smoking cessation program (based on cognitive-behavioral therapy) for inpatient alcohol-dependent smokers is more effective than a control condition (treatment as usual).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 13, 2012

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

August 20, 2009

Results QC Date

February 1, 2012

Last Update Submit

March 9, 2015

Conditions

Keywords

SmokingAlcoholOutcomeHarm reductionAlcohol drinkingTreatment outcomeTreatment effectiveness

Outcome Measures

Primary Outcomes (1)

  • Number of Smoke-free Patients

    Smoke-free defined with following measures: * patients self-report about smoking in the last 7 days (yes/no) * CO-level (smoke-free \<10ppm) * urine sample (cotinine)

    6 months

Secondary Outcomes (1)

  • Drinking in the Last 7 Days (Patients Report + Urine Sample)

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Cognitive-behavioural smoking cessation program

Behavioral: Cognitive-behavioural smoking cessation program

Control group

OTHER

Autogenic training

Behavioral: Autogenic training

Interventions

It's a cognitive-behavioural intervention for smoking cessation. Originally based on a 6 week program designed for outpatients (Batra \& Buchkremer 2004). This program was then specifically tailored for inpatient use with additional information addressing the interaction of smoking and drinking and its consequences.

Also known as: Nichtraucher in 6 Wochen (Batra & Buchkremer)
Intervention group

Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.

Also known as: Autogenous Training
Control group

Eligibility Criteria

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

You may qualify if:

  • alcohol-dependent
  • smoker
  • intend to stop or reduce smoking for at least 50%

You may not qualify if:

  • taking part in another smoking cessation program
  • being pregnant
  • not able to understand instruction due to cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Hospital of the University of Basel

Basel, CH-4025, Switzerland

Location

MeSH Terms

Conditions

Smoking CessationAlcohol DrinkingSmokingHarm Reduction

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDrinking Behavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Originally two recruiting centers were planned, what failed. Though less subjects than expected.

Results Point of Contact

Title
M. Sc. S. Müller (Site-investigator) Prof. G. A. Wiesbeck (PI)
Organization
Divsion Substance Use Disorder, Psychiatric Hospital of the Univeristy of Basel

Study Officials

  • Gerhard A. Wiesbeck, Prof. Dr.

    Psychiatric Hospital of the University of Basel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

July 1, 2007

Primary Completion

January 1, 2010

Study Completion

August 1, 2011

Last Updated

March 27, 2015

Results First Posted

April 13, 2012

Record last verified: 2015-03

Locations