Bupropion and Cigarette-Related Cues in Smokers

Phase 1CompletedNCT03920319

University of California, Los Angeles34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Smoking Smoking, Tobacco

Interventions

BupropionDRUG

Bupropion 150 mg sustained release

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

Cigarettes per day

Self-reported number of cigarettes smoked daily during the past 7 days \[??\]

Time frame: 8 weeks

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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