A Phase 2 interventional study of Bupropion Hydrochloride in Smoking Cessation, Smoking, Tobacco and Smoking (Tobacco) Addiction, sponsored by University of Southern California. Terminated at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University of Southern California · Phase 2, Interventional, and Treatment
This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.
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.
350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.
This study's enrollment of 12 is below the median of 150 across 326 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Antidepressant that is also effective in smoking cessation
Also known as: Bupropion
Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
Self report of smoking status
Time frame: Through study completion, an average of 26 months
Smoking cessation milestones
Smoking timeline follow back interview
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 26 months
Self report scale for Attention deficit/Hyperactivity disorder (ADHD)
ADHD symptom report
Time frame: Baseline visit
Snaithe-Hamilton Pleasure Scale (SHAPS)
Anhedonia scale
Time frame: Baseline visit and Week 8 post quit date
Objective body weight
Measured with a medical grade scale
Time frame: Baseline visit and Week 8 post quit date
Body adiposity via bioimpedence monitor
Measures body fat percentage/ BMI
Time frame: Baseline visit and Week 8 post quit date
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Plan to share: No
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupropion
University of Southern California →