High Dose Bupropion for Smoking Cessation - Pilot Study

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

Detailed Description
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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.

Official Title
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High Dose Bupropion Treatment for Smoking Cessation - Pilot Study

Conditions
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Smoking Cessation, Smoking, Tobacco, Smoking (Tobacco) Addiction, Cessation, Tobacco, Cigarette Smoking

Intervention / Treatment
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* Drug: Bupropion Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BUP-300<br>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<br>* Antidepressant that is also effective in smoking cessation<br>* Other names: Bupropion;|
| Experimental: BUP-450<br>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<br>* Antidepressant that is also effective in smoking cessation<br>* Other names: Bupropion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed] | 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 | Smoking timeline follow back interview | Through study completion, an average of 26 months | 
| 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. | Through study completion, an average of 26 months | 
| 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. | Through study completion, an average of 26 months | 
| 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. | Through study completion, an average of 26 months | 
| Self report scale for Attention deficit/Hyperactivity disorder (ADHD) | ADHD symptom report | Baseline visit | 
| Snaithe-Hamilton Pleasure Scale (SHAPS) | Anhedonia scale | Baseline visit and Week 8 post quit date | 
| Objective body weight | Measured with a medical grade scale | Baseline visit and Week 8 post quit date | 
| Body adiposity via bioimpedence monitor | Measures body fat percentage/ BMI | Baseline visit and Week 8 post quit date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupropion, Smokers, Smoking cessation, Cigarette smoking, Cigarette