NCT03920319

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2004

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2005

Completed
13.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 13, 2019

Last Update Submit

April 17, 2019

Conditions

SmokingSmoking, Tobacco

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Exhaled carbon monoxide (CO)

    8 weeks

  • Cigarettes per day

    8 weeks

  • Fagerström Test for Nicotine Dependence (FTND)

    8 weeks

Study Arms (2)

Bupropion

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

BupropionDRUG

Bupropion 150 mg sustained release

Also known as: bupropion HCl, Wellbutrin
Bupropion
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment-seeking cigarette smoker
  • Meet DSM-IV criteria for nicotine dependence
  • Negative result on urine test for drug use during screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SmokingTobacco Smoking

Interventions

Bupropion

Condition Hierarchy (Ancestors)

BehaviorTobacco Use

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Matching placebo pills
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, before-after controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 18, 2019

Study Start

January 1, 2004

Primary Completion

December 31, 2005

Study Completion

December 31, 2005

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share