Status:
TERMINATED
High Dose Bupropion for Smoking Cessation - Pilot Study
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
University of California, Los Angeles
University of California, San Diego
Conditions:
Smoking Cessation
Smoking, Tobacco
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Smokes cigarettes daily for at least 1 year
- Breath CO of 5 ppm or higher at Baseline visit
- Age 21 - 65
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03326128
Start Date
September 1 2021
End Date
July 1 2023
Last Update
July 17 2023
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033