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

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

U.S. FDA Resources

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®

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

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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, Styria
	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

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

Keywords provided by Medical University Innsbruck:

randomized controlled trial

smoking cessation

nicotine dependence

sustained-release bupropion

psychotherapy

psychodynamic model training

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Dopamine

Nicotine

Mental Disorders

Tobacco Use Disorder

Bupropion

Substance-Related Disorders

Disorders of Environmental Origin

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Medical University Innsbruck
Information provided by:	Medical University Innsbruck
ClinicalTrials.gov Identifier:	NCT00484692