STOP Study: Effectiveness of Zyban in a Clinical Population

NCT01015170 | Completed Phase 4 Results

• 1 other identifier: 005/2008
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 24

Brief Summary

Despite the significant health, social and economic costs of cigarette smoking, 17% of Ontarians still currently smoke. Use of smoking cessation pharmacotherapy such as Zyban (bupropion HCl) has been shown to double quit rates but such medications are under-utilized by smokers attempting to quit. It has been suggested that the high price of pharmacotherapy may act as a barrier to accessing such treatment.The main objective of this study is to evaluate the methods and effectiveness of providing smokers who want to quit with 8 weeks of free Zyban in combination with smoking cessation counselling through family health teams and community health centres across the province. Hypothesis: Ontario smokers who receive 8-weeks of free bupropion in combination with brief counselling will have higher smoking cessation rates than the standard population cessation rates.

Conditions

Cigarette Smoking; Nicotine Addiction; Smoking Cessation

Keywords

smoking cessation; nicotine addiction; Zyban; bupropion hydrochloride

Outcome Measures

Primary Outcomes (1)

• 7-day Point Prevalence of Smoking Abstinence

  Number of participants who report "Not Smoking (not even a puff) in past 7 days" when asked at week 8

  End of Treatment (8 weeks after Zyban start date)

Secondary Outcomes (2)

• Serious Quit Attempt (at Least 24 Hours of Abstinence)

  End of Treatment (8 weeks after Zyban start date)

• 7-day Point Prevalence of Smoking Abstinence

  6 months after Zyban start date

Study Arms (1)

Bupropion HCl

EXPERIMENTAL

Up to 8 week of bupropion SR (150mg BID) + counseling.

Drug: bupropion HCl

Interventions

bupropion HCl DRUG

150mg BID for up to 8 weeks + counseling

Also known as: Zyban

Bupropion HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ontario resident
• years of age or older
• Current daily cigarette smoker who smokes 10 or more cigarettes per day and has smoked \> 100 cigarettes in their lifetime
• Want to quit smoking cigarettes within 30 days of assessment
• Willingness and capacity to give written informed consent and to comply with study protocol

You may not qualify if:

• Enrollment in any of the STOP Study NRT models in the past 6 months
• Currently receiving Wellbutrin SR or any medication containing bupropion hydrochloride
• Current seizure disorder or history of seizures
• Current or prior diagnosis of bulimia or anorexia nervosa
• Current diagnosis of bipolar disorder
• History of head trauma
• Allergy or sensitivity to Zyban, Wellbutrin or bupropion
• Undergoing abrupt withdrawal from alcohol, benzodiazepines or other sedatives
• Currently taking monoamine oxidase (MAO) inhibitors, or thioridazine
• Pregnant or breastfeeding or at risk of becoming pregnant
• Central nervous system (CNS) tumor
• Severe hepatic impairment

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (24)

The Youth Centre

Ajax, Ontario, Canada

Location

Cottage Country Family Health Team

Bracebridge, Ontario, Canada

Location

Bramalea Community Health Centre

Brampton, Ontario, Canada

Location

Aberdeen Downtown Nurse Practitioner Clinic

Brantford, Ontario, Canada

Location

Beausoleil Family Health Centre

Christian Island, Ontario, L9M0A9, Canada

Location

Georgian Bay Family Health Team

Collingwood, Ontario, Canada

Location

North Renfrew Family Health Team

Deep River, Ontario, Canada

Location

Elliot Lake Family Health Team

Elliot Lake, Ontario, Canada

Location

Englehart & District Family Health Team

Englehart, Ontario, Canada

Location

Stonegate Community Health Centre

Etobicoke, Ontario, Canada

Location

Haliburton Highlands Family Health Team

Haliburton, Ontario, Canada

Location

Algonquin Family Health Team

Huntsville, Ontario, Canada

Location

Mary Beglund Community Health Centre

Ignace, Ontario, Canada

Location

NorWest Community Health Centre

Longlac, Ontario, Canada

Location

Summerville Family Health Team

Mississauga, Ontario, Canada

Location

Mount Forest Family Health Team

Mount Forest, Ontario, Canada

Location

Dufferin Area Family Health Team

Orangeville, Ontario, Canada

Location

Somerset West Community Health Centre

Ottawa, Ontario, Canada

Location

PrimaCare Community Family Health Team

Paris, Ontario, Canada

Location

West Durham Family Health Team

Pickering, Ontario, Canada

Location

Prince Edward Family Health Team

Picton, Ontario, Canada

Location

Stratford Family Health Team

Stratford, Ontario, Canada

Location

NorWest Community Health Centre

Thunder Bay, Ontario, Canada

Location

Sandwich Community Health Centre

Windsor, Ontario, Canada

Location

Related Publications (12)

• Alberg AJ, Stashefsky Margalit R, Burke A, Rasch KA, Stewart N, Kline JA, Ernst PA, Avey A, Hoffman SC. The influence of offering free transdermal nicotine patches on quit rates in a local health department's smoking cessation program. Addict Behav. 2004 Dec;29(9):1763-78. doi: 10.1016/j.addbeh.2004.04.007.

  PMID: 15530720 BACKGROUND

• Ahluwalia JS, Harris KJ, Catley D, Okuyemi KS, Mayo MS. Sustained-release bupropion for smoking cessation in African Americans: a randomized controlled trial. JAMA. 2002 Jul 24-31;288(4):468-74. doi: 10.1001/jama.288.4.468.

  PMID: 12132977 BACKGROUND

• Brody AL, Mandelkern MA, London ED, Childress AR, Lee GS, Bota RG, Ho ML, Saxena S, Baxter LR Jr, Madsen D, Jarvik ME. Brain metabolic changes during cigarette craving. Arch Gen Psychiatry. 2002 Dec;59(12):1162-72. doi: 10.1001/archpsyc.59.12.1162.

  PMID: 12470133 BACKGROUND

• Brody AL, Mandelkern MA, Lee G, Smith E, Sadeghi M, Saxena S, Jarvik ME, London ED. Attenuation of cue-induced cigarette craving and anterior cingulate cortex activation in bupropion-treated smokers: a preliminary study. Psychiatry Res. 2004 Apr 30;130(3):269-81. doi: 10.1016/j.pscychresns.2003.12.006.

  PMID: 15135160 BACKGROUND

• Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. doi: 10.1016/j.amepre.2004.09.007.

  PMID: 15626567 BACKGROUND

• Durcan MJ, Deener G, White J, Johnston JA, Gonzales D, Niaura R, Rigotti N, Sachs DP. The effect of bupropion sustained-release on cigarette craving after smoking cessation. Clin Ther. 2002 Apr;24(4):540-51. doi: 10.1016/s0149-2918(02)85130-x.

  PMID: 12017399 BACKGROUND

• Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.

  PMID: 11034670 BACKGROUND

• Hurt RD, Sachs DP, Glover ED, Offord KP, Johnston JA, Dale LC, Khayrallah MA, Schroeder DR, Glover PN, Sullivan CR, Croghan IT, Sullivan PM. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med. 1997 Oct 23;337(17):1195-202. doi: 10.1056/NEJM199710233371703.

  PMID: 9337378 BACKGROUND

• Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, Smith SS, Muramoto ML, Daughton DM, Doan K, Fiore MC, Baker TB. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999 Mar 4;340(9):685-91. doi: 10.1056/NEJM199903043400903.

  PMID: 10053177 BACKGROUND

• Leshner AI. Addiction is a brain disease, and it matters. Science. 1997 Oct 3;278(5335):45-7. doi: 10.1126/science.278.5335.45.

  PMID: 9311924 BACKGROUND

• Lerman C, Roth D, Kaufmann V, Audrain J, Hawk L, Liu A, Niaura R, Epstein L. Mediating mechanisms for the impact of bupropion in smoking cessation treatment. Drug Alcohol Depend. 2002 Jul 1;67(2):219-23. doi: 10.1016/s0376-8716(02)00067-4.

  PMID: 12095672 BACKGROUND

• Shiffman S, Johnston JA, Khayrallah M, Elash CA, Gwaltney CJ, Paty JA, Gnys M, Evoniuk G, DeVeaugh-Geiss J. The effect of bupropion on nicotine craving and withdrawal. Psychopharmacology (Berl). 2000 Jan;148(1):33-40. doi: 10.1007/s002130050022.

  PMID: 10663415 BACKGROUND

Related Links

• Click here for more information about the study: STOP Study: Effectiveness of Zyban in a Clinical Population
• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre.

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder; Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Peter Selby; Dr. Laurie Zawertailo Principal Investigator
• Organization: Centre for Addiction and Mental Health

laurie.zawertailo@camh.ca

416-535-8501

Study Officials

• Peter Selby, MD, MHSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Addictions Program

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (24)