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Randomized Trial of Ultrashort Psychotherapy vs Sustained-Release Bupropion for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00484692
First Posted: June 11, 2007
Last Update Posted: June 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University Innsbruck
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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®

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • point prevalence of self-reported abstinence confirmed by urine cotinine levels below the level of detection for each follow-up time point [ Time Frame: 12 months ]

Enrollment: 779
Study Start Date: July 2005
Study Completion Date: January 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An age of at least 18 years,
  • A cigarette consumption of at least 15 cigarettes per day in the last 3 months, and
  • The willingness to contribute EUR 70 to the treatment costs, regardless of the treatment modality.

Exclusion Criteria:

  • Any psychiatric diagnosis except nicotine or caffeine dependence,
  • Any current psychopharmacological treatment,
  • Known hypersensitivity to bupropion,
  • Epilepsy,
  • Liver cirrhosis,
  • Brain tumor,
  • Pregnancy (verified by an immunological test at the intake interview and 3 weeks after the first day of the first menses occurring within treatment),
  • Lactation,
  • Any serious or unstable cardiac,
  • Renal,
  • Hypertensive,
  • Pulmonary,
  • Endocrine, or neurologic disorder,
  • Ulcers,
  • Dermatologic disorders,
  • Current use of other smoking cessation treatments, and
  • Regular use of any noncigarette tobacco product
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484692


Locations
Austria
Institute for Clinical Psychology, Psychotherapy, and Health Promotion
Graz, Styria, Austria, A-8010
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Study Director: Gerald Zernig, M.D. Medical University Innsbruck
  More Information

ClinicalTrials.gov Identifier: NCT00484692     History of Changes
Other Study ID Numbers: EudraCT-Nr. 2005-006189-32
FWF grant P16394-B05
First Submitted: June 8, 2007
First Posted: June 11, 2007
Last Update Posted: June 11, 2007
Last Verified: June 2007

Keywords provided by Medical University Innsbruck:
randomized controlled trial
smoking cessation
nicotine dependence
sustained-release bupropion
psychotherapy
psychodynamic model training

Additional relevant MeSH terms:
Substance-Related Disorders
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors