Bupropion and Cigarette-Related Cues in Smokers

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

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 Overview

• Status: Completed
• Conditions: Smoking; Smoking, Tobacco
• Intervention / Treatment: Other: Placebo; Drug: Bupropion

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Bupropion; Bupropion 150 mg sustained release; Other Names: Wellbutrin; bupropion HCl
PLACEBO_COMPARATOR: 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.	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cigarettes per day	Self-reported number of cigarettes smoked daily during the past 7 days [??]	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.	8 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2004
• Primary Completion (ACTUAL): December 31, 2005
• Study Completion (ACTUAL): December 31, 2005

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: Brody011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No