Bupropion and Cigarette-Related Cues in Smokers

Phase 1

Completed

• Conditions: Smoking; Smoking, Tobacco
• Interventions: Other: Placebo; Drug: Bupropion

• Registration Number: NCT03920319
• Lead Sponsor: University of California, Los Angeles

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-01
• Primary Completion: 2005-12-31
• Study Completion: 2005-12-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants assigned to pill placebo daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment.
Bupropion	Bupropion	Participants assigned to 150mg of bupropion daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment.

Primary Outcome Measures

Name	Time	Method
Craving ratings	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Exhaled carbon monoxide (CO)	8 weeks	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.
Cigarettes per day	8 weeks	Self-reported number of cigarettes smoked daily during the past 7 days \[??\]
Fagerström Test for Nicotine Dependence (FTND)	8 weeks	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.