High Dose Bupropion for Smoking Cessation - Pilot Study

Smoking Cessation Clinical Trial

Official title:

High Dose Bupropion Treatment for Smoking Cessation - Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03326128
• Other study ID #: 1703346
• Status: Terminated
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Behavior, Addictive
• Cessation, Tobacco
• Cigarette Smoking
• Smoking (Tobacco) Addiction
• Smoking Cessation
• Smoking, Tobacco

Intervention

Drug:
• Bupropion Hydrochloride
Antidepressant that is also effective in smoking cessation

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	University of California, Los Angeles, University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — 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

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. — View 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. — 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

Outcome

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