High Dose Bupropion for Smoking Cessation - Pilot Study

Phase 2

Terminated

• Conditions: Smoking (Tobacco) Addiction; Smoking Cessation; Smoking, Tobacco; Cessation, Tobacco; Cigarette Smoking
• Interventions: Drug: Bupropion Hydrochloride

• Registration Number: NCT03326128
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Study Start: 2021-09-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUP-300	Bupropion Hydrochloride	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.
BUP-450	Bupropion Hydrochloride	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)	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.
Snaithe-Hamilton Pleasure Scale (SHAPS)	Baseline visit and Week 8 post quit date	Anhedonia scale
Inventory of Depressive and Anxious Symptomology (General depression subscale)	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.
Self report scale for Attention deficit/Hyperactivity disorder (ADHD)	Baseline visit	ADHD symptom report
Objective body weight	Baseline visit and Week 8 post quit date	Measured with a medical grade scale
Body adiposity via bioimpedence monitor	Baseline visit and Week 8 post quit date	Measures body fat percentage/ BMI
Smoking cessation milestones	Through study completion, an average of 26 months	Smoking timeline follow back interview
Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)	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.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States