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High Dose Bupropion for Smoking Cessation - Pilot Study

Primary Purpose

Smoking Cessation, Smoking, Tobacco, Smoking (Tobacco) Addiction

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion Hydrochloride
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Bupropion, Smokers, Smoking cessation, Cigarette smoking, Cigarette

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • smokes >= 10 cigarettes per day for >= 2 years
  • has breath CO ppm >= 10 ppm on intake
  • Age 21 - 65

Exclusion Criteria:

  • Past year moderate- severe DSM-5 non-tobacco substance use disorder (4+ symptoms)
  • Possible drug contraindications (Panic, bipolar, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)
  • current use of other cessation medication
  • current use of e-cigarettes or other tobacco products > 2X/week
  • history of bupropion use
  • current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use
  • currently or plan to be pregnant or breastfeeding

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BUP-300

BUP-450

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
Self report of smoking status

Secondary Outcome Measures

Smoking cessation milestones
Smoking timeline follow back interview
Inventory of Depressive and Anxious Symptomology (General depression subscale)
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.
Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)
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.
Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)
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.
Self report scale for Attention deficit/Hyperactivity disorder (ADHD)
ADHD symptom report
Snaithe-Hamilton Pleasure Scale (SHAPS)
Anhedonia scale
Objective body weight
Measured with a medical grade scale
Body adiposity via bioimpedence monitor
Measures body fat percentage/ BMI

Full Information

First Posted
October 18, 2017
Last Updated
July 13, 2023
Sponsor
University of Southern California
Collaborators
University of California, Los Angeles, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03326128
Brief Title
High Dose Bupropion for Smoking Cessation - Pilot Study
Official Title
High Dose Bupropion Treatment for Smoking Cessation - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the COVID-19 pandemic, it was difficult to recruit eligible participants.
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Los Angeles, University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Tobacco, Smoking (Tobacco) Addiction, Cessation, Tobacco, Cigarette Smoking
Keywords
Bupropion, Smokers, Smoking cessation, Cigarette smoking, Cigarette

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.
Masking
Participant
Masking Description
Participants will be unaware of which medication condition they have been assigned to; however, the study team and the care provider will know which dose of medication they are distributing.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUP-300
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BUP-450
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupropion Hydrochloride
Other Intervention Name(s)
Bupropion
Intervention Description
Antidepressant that is also effective in smoking cessation
Primary Outcome Measure Information:
Title
Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
Description
Self report of smoking status
Time Frame
Through study completion, an average of 26 months
Secondary Outcome Measure Information:
Title
Smoking cessation milestones
Description
Smoking timeline follow back interview
Time Frame
Through study completion, an average of 26 months
Title
Inventory of Depressive and Anxious Symptomology (General depression subscale)
Description
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.
Time Frame
Through study completion, an average of 26 months
Title
Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)
Description
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.
Time Frame
Through study completion, an average of 26 months
Title
Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)
Description
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.
Time Frame
Through study completion, an average of 26 months
Title
Self report scale for Attention deficit/Hyperactivity disorder (ADHD)
Description
ADHD symptom report
Time Frame
Baseline visit
Title
Snaithe-Hamilton Pleasure Scale (SHAPS)
Description
Anhedonia scale
Time Frame
Baseline visit and Week 8 post quit date
Title
Objective body weight
Description
Measured with a medical grade scale
Time Frame
Baseline visit and Week 8 post quit date
Title
Body adiposity via bioimpedence monitor
Description
Measures body fat percentage/ BMI
Time Frame
Baseline visit and Week 8 post quit date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M Leventhal, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19062199
Citation
Leventhal AM, Kahler CW, Ray LA, Zimmerman M. Refining the depression-nicotine dependence link: patterns of depressive symptoms in psychiatric outpatients with current, past, and no history of nicotine dependence. Addict Behav. 2009 Mar;34(3):297-303. doi: 10.1016/j.addbeh.2008.11.008. Epub 2008 Nov 21.
Results Reference
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Brown RA, Niaura R, Lloyd-Richardson EE, Strong DR, Kahler CW, Abrantes AM, Abrams D, Miller IW. Bupropion and cognitive-behavioral treatment for depression in smoking cessation. Nicotine Tob Res. 2007 Jul;9(7):721-30. doi: 10.1080/14622200701416955.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
25231408
Citation
Ameringer KJ, Chou CP, Leventhal AM. Shared versus specific features of psychological symptoms and cigarettes per day: structural relations and mediation by negative- and positive-reinforcement smoking. J Behav Med. 2015 Apr;38(2):224-36. doi: 10.1007/s10865-014-9597-y. Epub 2014 Sep 18.
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PubMed Identifier
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Citation
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PubMed Identifier
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Boutelle KN, Braden A, Douglas JM, Rhee KE, Strong D, Rock CL, Wilfley DE, Epstein L, Crow S. Design of the FRESH study: A randomized controlled trial of a parent-only and parent-child family-based treatment for childhood obesity. Contemp Clin Trials. 2015 Nov;45(Pt B):364-370. doi: 10.1016/j.cct.2015.09.007. Epub 2015 Sep 8.
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PubMed Identifier
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Boutelle KN, Liang J, Knatz S, Matheson B, Risbrough V, Strong D, Rhee KE, Craske MG, Zucker N, Bouton ME. Design and implementation of a study evaluating extinction processes to food cues in obese children: the Intervention for Regulations of Cues Trial (iROC). Contemp Clin Trials. 2015 Jan;40:95-104. doi: 10.1016/j.cct.2014.11.011. Epub 2014 Nov 22.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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High Dose Bupropion for Smoking Cessation - Pilot Study

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