About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Bupropion and Cigarette-Related Cues in Smokers

Clinicaltrials.gov identifier NCT03920319

Recruitment Status Completed

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

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).

  • Condition or Disease:Smoking
    Smoking, Tobacco
  • Intervention/Treatment: Drug: Bupropion
    Other: Placebo
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 34 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Randomized, double-blind, before-after controlled trial
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Basic Science
  • Official Title: Effect of Bupropion Treatment on Brain Activation Induced by Cigarette-Related Cues in Smokers
  • Actual Study Start Date: January 2004
  • Actual Primary Completion Date: December 2005
  • Actual Study Completion Date: December 2005
Arms and interventions
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Craving ratings [ Time Frame: 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: 1. Cigarettes per day [ Time Frame: 8 weeks ]
    Self-reported number of cigarettes smoked daily during the past 7 days [??]
  • 2. Fagerström Test for Nicotine Dependence (FTND) [ Time Frame: 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.
  • 3. Exhaled carbon monoxide (CO) [ Time Frame: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
Criteria

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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of California, Los Angeles

More Information
  • Responsible Party: University of California, Los Angeles
  • ClinicalTrials.gov Identifier: NCT03920319 History of Changes
  • Other Study ID Numbers: Brody011
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes