Not provided
Not provided
Not provided
Not provided
Not provided
Due to the COVID-19 pandemic, it was difficult to recruit eligible participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| University of California, San Diego | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUP-300 | Active Comparator | 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. |
|
| BUP-450 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion Hydrochloride | Drug | Antidepressant that is also effective in smoking cessation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed] | Self report of smoking status | Through study completion, an average of 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation milestones | Smoking timeline follow back interview | Through study completion, an average of 26 months |
| Inventory of Depressive and Anxious Symptomology (General depression subscale) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam M Leventhal, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19062199 | Background | 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. | |
| 17577801 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2017 | Oct 23, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D016739 | Behavior, Addictive |
| D020340 | Tobacco Use Cessation |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D003192 | Compulsive Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.
Not provided
Not provided
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.
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 |
| 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 |
| 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 |
| Self report scale for Attention deficit/Hyperactivity disorder (ADHD) | ADHD symptom report | Baseline visit |
| Snaithe-Hamilton Pleasure Scale (SHAPS) | Anhedonia scale | Baseline visit and Week 8 post quit date |
| Objective body weight | Measured with a medical grade scale | Baseline visit and Week 8 post quit date |
| Body adiposity via bioimpedence monitor | Measures body fat percentage/ BMI | Baseline visit and Week 8 post quit date |
| Brown RA, Niaura R, Lloyd-Richardson EE, Strong DR, Kahler CW, Abrantes AM, Abrams D, Miller IW. Bupropion and cognitive-behavioral treatment for depression in smoking cessation. Nicotine Tob Res. 2007 Jul;9(7):721-30. doi: 10.1080/14622200701416955. |
| 16027765 | Background | Fava M, Rush AJ, Thase ME, Clayton A, Stahl SM, Pradko JF, Johnston JA. 15 years of clinical experience with bupropion HCl: from bupropion to bupropion SR to bupropion XL. Prim Care Companion J Clin Psychiatry. 2005;7(3):106-13. doi: 10.4088/pcc.v07n0305. |
| 25231408 | Background | 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. |
| 20836607 | Background | Leventhal AM, Mickens L, Dunton GF, Sussman S, Riggs NR, Pentz MA. Tobacco use moderates the association between major depression and obesity. Health Psychol. 2010 Sep;29(5):521-8. doi: 10.1037/a0020854. |
| 27116704 | Background | Boutelle KN, Monreal T, Strong DR, Amir N. An open trial evaluating an attention bias modification program for overweight adults who binge eat. J Behav Ther Exp Psychiatry. 2016 Sep;52:138-146. doi: 10.1016/j.jbtep.2016.04.005. Epub 2016 Apr 16. |
| 26358536 | Background | Boutelle KN, Braden A, Douglas JM, Rhee KE, Strong D, Rock CL, Wilfley DE, Epstein L, Crow S. Design of the FRESH study: A randomized controlled trial of a parent-only and parent-child family-based treatment for childhood obesity. Contemp Clin Trials. 2015 Nov;45(Pt B):364-370. doi: 10.1016/j.cct.2015.09.007. Epub 2015 Sep 8. |
| 25461494 | Background | Boutelle KN, Liang J, Knatz S, Matheson B, Risbrough V, Strong D, Rhee KE, Craske MG, Zucker N, Bouton ME. Design and implementation of a study evaluating extinction processes to food cues in obese children: the Intervention for Regulations of Cues Trial (iROC). Contemp Clin Trials. 2015 Jan;40:95-104. doi: 10.1016/j.cct.2014.11.011. Epub 2014 Nov 22. |
| 24399554 | Background | Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185. |
| 22311383 | Background | 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. |
| 24886011 | Background | 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. |
| 23896304 | Background | 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. |
| D007175 |
| Impulsive Behavior |