Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-09 @ 1:18 PM
Study NCT ID:
NCT03326128
Status:
TERMINATED
Last Update Posted:
2023-07-17
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Bupropion for Smoking Cessation - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-25', 'size': 1056947, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-23T17:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Due to the COVID-19 pandemic, it was difficult to recruit eligible participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]', 'timeFrame': 'Through study completion, an average of 26 months', 'description': 'Self report of smoking status'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation milestones', 'timeFrame': 'Through study completion, an average of 26 months', 'description': 'Smoking timeline follow back interview'}, {'measure': 'Inventory of Depressive and Anxious Symptomology (General depression subscale)', 'timeFrame': 'Through study completion, an average of 26 months', 'description': '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.'}, {'measure': 'Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)', 'timeFrame': 'Through study completion, an average of 26 months', 'description': '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.'}, {'measure': 'Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)', 'timeFrame': 'Through study completion, an average of 26 months', 'description': '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.'}, {'measure': 'Self report scale for Attention deficit/Hyperactivity disorder (ADHD)', 'timeFrame': 'Baseline visit', 'description': 'ADHD symptom report'}, {'measure': 'Snaithe-Hamilton Pleasure Scale (SHAPS)', 'timeFrame': 'Baseline visit and Week 8 post quit date', 'description': 'Anhedonia scale'}, {'measure': 'Objective body weight', 'timeFrame': 'Baseline visit and Week 8 post quit date', 'description': 'Measured with a medical grade scale'}, {'measure': 'Body adiposity via bioimpedence monitor', 'timeFrame': 'Baseline visit and Week 8 post quit date', 'description': 'Measures body fat percentage/ BMI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bupropion', 'Smokers', 'Smoking cessation', 'Cigarette smoking', 'Cigarette'], 'conditions': ['Smoking Cessation', 'Smoking, Tobacco', 'Smoking (Tobacco) Addiction', 'Cessation, Tobacco', 'Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '19062199', 'type': 'BACKGROUND', '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.'}, {'pmid': '17577801', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16027765', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25231408', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20836607', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27116704', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26358536', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25461494', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24399554', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22311383', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24886011', 'type': 'BACKGROUND', '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.'}, {'pmid': '23896304', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokes cigarettes daily for at least 1 year\n* Breath CO of 5 ppm or higher at Baseline visit\n* Age 21 - 65\n\nExclusion Criteria:\n\n* Possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)\n* Unstable cardiovascular disorder or uncontrolled hypertension\n* Severe renal/hepatic impairment based on serology evaluation\n* History of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury\n* Current use of other cessation medication or counseling\n* History of bupropion use\n* Current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, CYP2B6 inhibitors, CYP2B6 inducers, drug metabolized by CYP2D6\n* Sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs\n* Current (past 30 days) use of illicit or medical use of prescription stimulants\n* Currently or plan to be pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03326128', 'briefTitle': 'High Dose Bupropion for Smoking Cessation - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'High Dose Bupropion Treatment for Smoking Cessation - Pilot Study', 'orgStudyIdInfo': {'id': '1703346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BUP-300', 'description': '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.', 'interventionNames': ['Drug: Bupropion Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'BUP-450', 'description': '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.', 'interventionNames': ['Drug: Bupropion Hydrochloride']}], 'interventions': [{'name': 'Bupropion Hydrochloride', 'type': 'DRUG', 'otherNames': ['Bupropion'], 'description': 'Antidepressant that is also effective in smoking cessation', 'armGroupLabels': ['BUP-300', 'BUP-450']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Adam M Leventhal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Leventhal', 'investigatorAffiliation': 'University of Southern California'}}}}