Bupropion and Cigarette-Related Cues in Smokers

Smoking Clinical Trial

Official title:

Effect of Bupropion Treatment on Brain Activation Induced by Cigarette-Related Cues in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920319
• Other study ID #: Brody011
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2004
• Est. completion date: December 31, 2005

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind, before-after controlled trial to assess changes in regional brain activation in response to cigarette-related cues from before to after treatment with bupropion (vs placebo).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2005
• Est. primary completion date: December 31, 2005
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Treatment-seeking cigarette smoker

• Meet DSM-IV criteria for nicotine dependence

• Negative result on urine test for drug use during screening

Exclusion Criteria:

• History of any Axis I psychiatric diagnosis other than nicotine dependence

• Medical conditions that might affect brain function

• Current use of medications that could alter brain function

• Pregnancy

• Current illicit drug use other than occasional use of marijuana

Related Conditions & MeSH terms

• Smoking
• Smoking, Tobacco

Intervention

Drug:
• Bupropion
Bupropion 150 mg sustained release

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving ratings	Participants were instructed to respond from 1 (definitely not) to 5 (definitely) on the question, "I crave a cigarette right now", after viewing video cues.	8 weeks
Secondary	Exhaled carbon monoxide (CO)	Participants were asked to hold their breath for as long as possible, ideally 15 seconds, then to breathe out slowly into the mouthpiece of a CO monitor, aiming to empty the lungs completely.	8 weeks
Secondary	Cigarettes per day	Self-reported number of cigarettes smoked daily during the past 7 days [??]	8 weeks
Secondary	Fagerström Test for Nicotine Dependence (FTND)	The FTND contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.	8 weeks