High Dose Bupropion for Smoking Cessation - Pilot Study

NCT03326128 | Terminated Phase 2 FDA Drug

• 1 other identifier: 1703346
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.

Conditions

Smoking Cessation; Smoking, Tobacco; Smoking (Tobacco) Addiction; Cessation, Tobacco; Cigarette Smoking

Keywords

Bupropion; Smokers; Smoking cessation; Cigarette smoking; Cigarette

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Smoking cessation milestones

  Through study completion, an average of 26 months

• Inventory of Depressive and Anxious Symptomology (General depression subscale)

  Through study completion, an average of 26 months

• Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)

  Through study completion, an average of 26 months

• Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)

  Through study completion, an average of 26 months

• Self report scale for Attention deficit/Hyperactivity disorder (ADHD)

  Baseline visit

Study Arms (2)

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.

Drug: Bupropion Hydrochloride

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.

Drug: Bupropion Hydrochloride

Interventions

Bupropion Hydrochloride DRUG

Antidepressant that is also effective in smoking cessation

Also known as: Bupropion

BUP-300; BUP-450

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokes cigarettes daily for at least 1 year
• Breath CO of 5 ppm or higher at Baseline visit
• Age 21 - 65

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (12)

• 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: 19062199 BACKGROUND

• 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: 17577801 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.

  PMID: 16027765 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.

  PMID: 25231408 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.

  PMID: 20836607 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.

  PMID: 27116704 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.

  PMID: 26358536 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.

  PMID: 25461494 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.

  PMID: 24399554 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.

  PMID: 22311383 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.

  PMID: 24886011 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.

  PMID: 23896304 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking; Smoking; Behavior, Addictive; Tobacco Use Cessation; Cigarette Smoking

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Adam M Leventhal, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 31, 2017
• Study Start: September 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)