Trial Outcomes & Findings for Smoking Cessation in Alcoholics (NCT NCT00963482)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

6 months

Results posted on

2015-03-27

Participant Flow

01.07.2007-31.01.2010 Recruiting process 31.01.2010-31.07.2011 last follow-up sessions location of recruiting: alcohol detoxification unit follow-up: outpatient

Out of 237 screened patients, 103 were enrolled. Intervention group(EG)=53; Control group (CG)=50.

Participant milestones

Participant milestones
Measure	Intervention Group Cognitive-behavioural smoking cessation program	Control Group Autogenic training
Overall Study STARTED	53	50
Overall Study COMPLETED	25	33
Overall Study NOT COMPLETED	28	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Cessation in Alcoholics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=53 Participants Cognitive-behavioural smoking cessation program	Control Group n=50 Participants Autogenic training	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	50 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 11 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=7 Participants	44 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment Switzerland	53 participants n=5 Participants	50 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention-to-treat analysis

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)

Outcome measures

Outcome measures
Measure	Intervention Group n=46 Participants Cognitive-behavioural smoking cessation program	Control Group n=43 Participants Autogenic training
Number of Smoke-free Patients	0 participants	3 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

M. Sc. S. Müller (Site-investigator) Prof. G. A. Wiesbeck (PI)

Divsion Substance Use Disorder, Psychiatric Hospital of the Univeristy of Basel

Phone: +41 61 325 53 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place