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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Treatments: Bupropion

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