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

This study has been completed.
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00484692
First received: June 8, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00484692     History of Changes
Other Study ID Numbers: EudraCT-Nr. 2005-006189-32, FWF grant P16394-B05
Study First Received: June 8, 2007
Last Updated: June 8, 2007
Health Authority: Austria: Federal Ministry for Health and Women

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013