Clinical trial NCT03326128: High Dose Bupropion for Smoking Cessation - Pilot Study
Official title: High Dose Bupropion Treatment for Smoking Cessation - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Smoking Cessation
Smoking, Tobacco
Smoking (Tobacco) Addiction
Cessation, Tobacco
Cigarette Smoking
Keywords: Bupropion
Smokers
Smoking cessation
Cigarette smoking
Cigarette
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, San Diego
First posted: 2017-10-31
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to receive either 300 or 450 mg of Bupropion.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
timeFrame: Through study completion, an average of 26 months
Secondary outcomes:
measure: Smoking cessation milestones
timeFrame: Through study completion, an average of 26 months
measure: Inventory of Depressive and Anxious Symptomology (General depression subscale)
timeFrame: Through study completion, an average of 26 months
measure: Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)
timeFrame: Through study completion, an average of 26 months
measure: Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)
timeFrame: Through study completion, an average of 26 months
measure: Self report scale for Attention deficit/Hyperactivity disorder (ADHD)
timeFrame: Baseline visit
measure: Snaithe-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline visit and Week 8 post quit date
measure: Objective body weight
timeFrame: Baseline visit and Week 8 post quit date
measure: Body adiposity via bioimpedence monitor
timeFrame: Baseline visit and Week 8 post quit date
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Adam M Leventhal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.