High Dose Bupropion for Smoking Cessation - Pilot Study

July 13, 2023 updated by: Adam Leventhal, University of Southern California

High Dose Bupropion Treatment for Smoking Cessation - Pilot Study

This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomly assigned to either receive 300 mg of BUP or 450 mg of BUP for 8 weeks with an aim to quit smoking. In addition, participants will simultaneously receive counseling to set a quit date and stay motivated to quit. Medication will be administered up to 4 weeks before and for 4 weeks after designated quit-date. Post-treatment follow-up appointment will be scheduled for 8, 16, and 26 weeks post treatment to assess commitment to quitting and overall success of the study.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Smokes cigarettes daily for at least 1 year
  • Breath CO of 5 ppm or higher at Baseline visit
  • Age 21 - 65

Exclusion Criteria:

  • Possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)
  • Unstable cardiovascular disorder or uncontrolled hypertension
  • Severe renal/hepatic impairment based on serology evaluation
  • History of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury
  • Current use of other cessation medication or counseling
  • History of bupropion use
  • Current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, CYP2B6 inhibitors, CYP2B6 inducers, drug metabolized by CYP2D6
  • Sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
  • Current (past 30 days) use of illicit or medical use of prescription stimulants
  • Currently or plan to be pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BUP-300
Participants will receive Bupropion hydrochloride for 10 weeks and titrate to a maximum dose of 300 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
Drug: Bupropion Hydrochloride
Antidepressant that is also effective in smoking cessation
Other Names:
  • Bupropion
Experimental: BUP-450
Participants will receive Bupropion hydrochloride for 12 weeks and titrate to a maximum dose of 450 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
Drug: Bupropion Hydrochloride
Antidepressant that is also effective in smoking cessation
Other Names:
  • Bupropion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
Time Frame: Through study completion, an average of 26 months
Self report of smoking status
Through study completion, an average of 26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation milestones
Time Frame: Through study completion, an average of 26 months
Smoking timeline follow back interview
Through study completion, an average of 26 months
Self report scale for Attention deficit/Hyperactivity disorder (ADHD)
Time Frame: Baseline visit
ADHD symptom report
Baseline visit
Snaithe-Hamilton Pleasure Scale (SHAPS)
Time Frame: Baseline visit and Week 8 post quit date
Anhedonia scale
Baseline visit and Week 8 post quit date
Objective body weight
Time Frame: Baseline visit and Week 8 post quit date
Measured with a medical grade scale
Baseline visit and Week 8 post quit date
Body adiposity via bioimpedence monitor
Time Frame: Baseline visit and Week 8 post quit date
Measures body fat percentage/ BMI
Baseline visit and Week 8 post quit date
Inventory of Depressive and Anxious Symptomology (General depression subscale)
Time Frame: Through study completion, an average of 26 months
This measure is obtained through the completion of the Inventory of Depressive and Anxious Symptomology General depression subscale. A total score will be calculated. Scores can range from 4 to 20 with the lower scores representing lower levels of depression and higher scores representing higher levels of depression.
Through study completion, an average of 26 months
Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)
Time Frame: Through study completion, an average of 26 months
This measure is obtained through the completion of the Inventory of Depressive and Anxious Symptomology Social anxiety subscale. A total score will be calculated. Scores can range from 4 to 20 with the lower scores representing lower levels of social anxiety and higher scores representing higher levels of social anxiety.
Through study completion, an average of 26 months
Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)
Time Frame: Through study completion, an average of 26 months
This measure is obtained through the completion of the Inventory of Depressive and Anxious Symptomology Traumatic intrusions subscale. A total score will be calculated. Scores can range from 4 to 20 with the lower scores representing fewer traumatic intrusions and g scores representing greater traumatic intrusions.
Through study completion, an average of 26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

University of California, San Diego
University of California, Los Angeles

Investigators

  • Principal Investigator: Adam M Leventhal, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703346

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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