Smoking Cessation Clinical Trial
Official title:
High Dose Bupropion Treatment for Smoking Cessation - Pilot Study
Verified date | July 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.
Status | Terminated |
Enrollment | 12 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | University of California, Los Angeles, University of California, San Diego |
United States,
Ameringer KJ, Chou CP, Leventhal AM. Shared versus specific features of psychological symptoms and cigarettes per day: structural relations and mediation by negative- and positive-reinforcement smoking. J Behav Med. 2015 Apr;38(2):224-36. doi: 10.1007/s10865-014-9597-y. Epub 2014 Sep 18. — View Citation
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Leventhal AM, Ameringer KJ, Osborn E, Zvolensky MJ, Langdon KJ. Anxiety and depressive symptoms and affective patterns of tobacco withdrawal. Drug Alcohol Depend. 2013 Dec 1;133(2):324-9. doi: 10.1016/j.drugalcdep.2013.06.015. Epub 2013 Jul 26. — View Citation
Leventhal AM, Kahler CW, Ray LA, Zimmerman M. Refining the depression-nicotine dependence link: patterns of depressive symptoms in psychiatric outpatients with current, past, and no history of nicotine dependence. Addict Behav. 2009 Mar;34(3):297-303. doi: 10.1016/j.addbeh.2008.11.008. Epub 2008 Nov 21. — View Citation
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Leventhal AM, Munafo M, Tidey JW, Sussman S, Monterosso JR, Sun P, Kahler CW. Anhedonia predicts altered processing of happy faces in abstinent cigarette smokers. Psychopharmacology (Berl). 2012 Jul;222(2):343-51. doi: 10.1007/s00213-012-2649-5. Epub 2012 Feb 4. — View Citation
Leventhal AM, Trujillo M, Ameringer KJ, Tidey JW, Sussman S, Kahler CW. Anhedonia and the relative reward value of drug and nondrug reinforcers in cigarette smokers. J Abnorm Psychol. 2014 May;123(2):375-86. doi: 10.1037/a0036384. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Smoking cessation milestones | Smoking timeline follow back interview | Through study completion, an average of 26 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Self report scale for Attention deficit/Hyperactivity disorder (ADHD) | ADHD symptom report | Baseline visit | |
Secondary | Snaithe-Hamilton Pleasure Scale (SHAPS) | Anhedonia scale | Baseline visit and Week 8 post quit date | |
Secondary | Objective body weight | Measured with a medical grade scale | Baseline visit and Week 8 post quit date | |
Secondary | Body adiposity via bioimpedence monitor | Measures body fat percentage/ BMI | Baseline visit and Week 8 post quit date |
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