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| Sponsored by: |
Medical University Innsbruck |
| Information provided by: | Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00484692 |
Purpose
Background
Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.
Methods
We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.
| Condition | Intervention | Phase |
|
Nicotine Dependence Substance Abuse Substance Dependence Tobacco Dependence |
Drug: sustained-release bupropion (Zyban(R)) Behavioral: Psychodynamic Model Training (R) = PDM(R) |
Phase IV |
| MedlinePlus related topics: | Quitting Smoking Smoking |
| Drug Information available for: | Bupropion hydrochloride Bupropion Nicotine polacrilex Nicotine tartrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training® |
| Enrollment: | 779 |
| Study Start Date: | July 2005 |
| Study Completion Date: | January 2007 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria, Styria | |||||
| Institute for Clinical Psychology, Psychotherapy, and Health Promotion | |||||
| Graz, Styria, Austria, A-8010 | |||||
| Medical University Innsbruck |
| Study Director: | Gerald Zernig, M.D. | Medical University Innsbruck |
More Information
| Study ID Numbers: | EudraCT-Nr. 2005-006189-32, FWF grant P16394-B05 |
| First Received: | June 8, 2007 |
| Last Updated: | June 8, 2007 |
| ClinicalTrials.gov Identifier: | NCT00484692 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
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