Randomized Trial of Ultrashort Psychotherapy vs Sustained-Release Bupropion for Smoking Cessation
NCT00484692 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 779
Last updated 2007-06-11
Summary
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.
Conditions
- Nicotine Dependence
- Substance Abuse
- Substance Dependence
- Tobacco Dependence
Interventions
- DRUG
-
sustained-release bupropion (Zyban(R))
- BEHAVIORAL
-
Psychodynamic Model Training (R) = PDM(R)
Sponsors & Collaborators
-
Medical University Innsbruck
lead OTHER
Principal Investigators
-
Gerald Zernig, M.D. · Medical University Innsbruck
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Completion
- 2007-01-31
Countries
- Austria
Study Locations
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