Smoking Cessation, Smoking, Tobacco, Smoking (Tobacco) Addiction, Cessation, Tobacco, Cigarette Smoking
Conditions
Keywords
Bupropion, Smokers, Smoking cessation, Cigarette smoking, Cigarette
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.
Interventions
Antidepressant that is also effective in smoking cessation
Sponsors
University of California, Los Angeles
University of California, San Diego
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be unaware of which medication condition they have been assigned to; however, the study team and the care provider will know which dose of medication they are distributing.
Intervention model description
Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation milestones | Through study completion, an average of 26 months | Smoking timeline follow back interview |
| 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. |
| 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. |
| 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. |
| Self report scale for Attention deficit/Hyperactivity disorder (ADHD) | Baseline visit | ADHD symptom report |
| Snaithe-Hamilton Pleasure Scale (SHAPS) | Baseline visit and Week 8 post quit date | Anhedonia scale |
| 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 |
Countries
United States
Outcome results
None listed