High Dose Bupropion for Smoking Cessation - Pilot Study

University of Southern California

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Bupropion Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03326128

1703346

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

BUP-300

Active Comparator group

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.

Treatment:

Drug: Bupropion Hydrochloride

BUP-450

Experimental group

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.

Treatment:

Drug: Bupropion Hydrochloride