Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01023659
• Collaborator: Ontario Ministry of Health and Long Term Care (Other)
• Enrollment: 893
• Location: 1
• Arms: 3
• Duration (Months): 20
• Patients Per Site Per Month: 44.6

Study Details

Study Description

Brief Summary

Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder; Smoking; Smoking Cessation	Drug: bupropion; Drug: varenicline; Behavioral: motivational emails	Phase 4

Detailed Description

Bupropion and varenicline are effective pharmacotherapies for smoking cessation, but their population level impact is limited by a combination of factors. Both bupropion and varenicline are only available through prescription, however smoking cessation clinics are few in number and only about 25% of smokers receive information on smoking cessation aids from their healthcare provider. Mass distribution approaches, bypassing clinics and physicians, have been successful for nicotine replacement therapy in many jurisdictions, including Ontario. However, bupropion and varenicline have the potential to make a greater impact given their superior results from the clinical trials. Bupropion and varenicline present a unique challenge as they are prescribed medications, therefore we have proposed a variant of the mass distribution method to test whether it is practical to distribute them to a large number of people over a expansive geographic area (i.e., Ontario).

We hypothesize that engaging smokers with the opportunity to receive free bupropion or varenicline, to initiate an appointment with their physician to obtain a prescription that would be filled and mailed to the smoker from a central pharmacy would be a logistically feasible approach to reach high number of smokers from a wide geographic area. Our second hypothesis is that consistent with the results from clinical studies, in the general population varenicline would be associated with a higher abstinence rate than bupropion, and both varenicline and bupropion groups would achieve higher abstinence rates than those making quit attempts without any pharmacotherapy aid.

This is an open label, proof-of-concept study, wherein 2000 eligible participants will have the opportunity to receive bupropion (Zyban®) or varenicline (Champix®) for 12 weeks in conjunction with weekly motivational emails. Eligible participants will discuss with their doctor which of the two medications is appropriate for them to use as smoking cessation aid. It is also possible that the participant and his/her doctor may decide not to pursue smoking cessation using either of these medications. These participants will form a third intervention group, receiving only the weekly motivational emails. All participants will set a quit date of their choosing, but those receiving medication will set a quit date 7 days after starting the medication. The participants will enroll in the study via the study's website, at which time they will read the consent form, answer the eligibility questions and complete the baseline questionnaire. Data related to the outcome measures and adverse events will be collected at 4, 8 and 12 weeks after the start of treatment and at 6 and 12 months after the end of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 893 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Innovative Approach to Maximizing the Impact of Efficacious Pharmacotherapies on Smoking Cessation Attempts.
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupropion + motivational emails participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.	Drug: bupropion; bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks; Other Names: Zyban ; Behavioral: motivational emails; brief motivational emails, sent weekly for 12 weeks
Active Comparator: Varenicline + motivational emails participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.	Drug: varenicline; varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks; Other Names: Champix ; Behavioral: motivational emails; brief motivational emails, sent weekly for 12 weeks
Active Comparator: Motivational emails participants receive weekly motivational emails for 12 weeks.	Behavioral: motivational emails; brief motivational emails, sent weekly for 12 weeks

Outcome Measures

Primary Outcome Measures

1. 7-day Point Prevalence of Abstinence [6-month]

   7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"

2. Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician [End of Treatment]

   Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• male or female, at least 18 years of age, resident of Ontario, smoke at least 10 cigarettes per day, had smoked daily for at least the past 3 months, had smoked at least 100 cigarettes in their lifetime and intended to quit smoking in the next 30 days.

Exclusion Criteria:

• history of brain injury or seizure(s); pregnancy, lactation or risk of becoming pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver impairment; or history of anorexia and /or bulimina.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction and Mental Health	Toronto	Ontario	Canada	M5T 1P7

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Peter Selby, MD, MHSc, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Peter Selby, Clinical Director, Addictions Program, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT01023659
• Other Study ID Numbers: 068/2009
• First Posted: Dec 2, 2009
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Peter Selby, Clinical Director, Addictions Program, Centre for Addiction and Mental Health: Smoking cessation; Bupropion; Varenicline; Population-level; Mass distribution; Drug Therapy
• Additional relevant MeSH terms: Tobacco Use Disorder; Bupropion; Varenicline

Study Results

Participant Flow

Recruitment Details	Participants visited the study website, provided consent and completed an on-line assessment. Eligible participants received a personalized script to take to their physician, who could prescribe varenicline or bupropion for 12 weeks, or neither.

Arm/Group Title	Bupropion + Motivational Emails	Motivational Emails	Varenicline + Motivational Emails
Arm/Group Description	participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
Period Title: Overall Study
STARTED	258	365	264
COMPLETED	185	137	165
NOT COMPLETED	73	228	99

Baseline Characteristics

Arm/Group Title	Bupropion + Motivational Emails	Motivational Emails	Varenicline + Motivational Emails	Total
Arm/Group Description	participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks	Total of all reporting groups
Overall Participants	258	365	264	887
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.4 (12.2)	38.6 (12.0)	44.0 (12.8)	41.9 (12.3)
Sex: Female, Male (Count of Participants)
Female	150 58.1%	196 53.7%	157 59.5%	503 56.7%
Male	108 41.9%	169 46.3%	107 40.5%	384 43.3%
Region of Enrollment (participants) [Number]
Canada	258 100%	365 100%	264 100%	887 100%
Education level- less than high school diploma (Count of Participants)
Count of Participants [Participants]	59 22.9%	94 25.8%	58 22%	211 23.8%
Annual household income:$20,000 or less (Count of Participants)
Count of Participants [Participants]	116 45%	164 44.9%	93 35.2%	373 42.1%
# Participants currently employed (Count of Participants)
Count of Participants [Participants]	136 52.7%	198 54.2%	138 52.3%	472 53.2%
# cigarettes smoked per day (participants) [Number]
10-19 cpd	81 31.4%	131 35.9%	87 33%	299 33.7%
20-29 cpd	133 51.6%	186 51%	138 52.3%	457 51.5%
30 + cpd	44 17.1%	48 13.2%	39 14.8%	131 14.8%
# participants who smoke first morning cigarette within 5 minutes (Count of Participants)
Count of Participants [Participants]	122 47.3%	186 51%	118 44.7%	426 48%
Years since started smoking daily (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (12.1)	24.2 (12.0)	30.0 (12.7)	27.5 (12.2)
# participants with less than 3 quit attempts (Count of Participants)
Count of Participants [Participants]	140 54.3%	220 60.3%	118 44.7%	478 53.9%
Confidence in Quitting (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.8 (2.2)	7.5 (2.1)	7.8 (2.0)	7.7 (2.1)
# Participants who report previous use of smoking cessation medication (Count of Participants)
Count of Participants [Participants]	142 55%	186 51%	142 53.8%	470 53%
# participants with longest period of abstinence from smoking- less than 1 week (Count of Participants)
less than 1 week	75 29.1%	115 31.5%	74 28%	264 29.8%
1 week or more	183 70.9%	250 68.5%	190 72%	623 70.2%
Participants who report all or most of my friends smoke (Count of Participants)
Count of Participants [Participants]	80 31%	180 49.3%	84 31.8%	344 38.8%
Lives with other smoker(s) (Count of Participants)
Count of Participants [Participants]	140 54.3%	219 60%	139 52.7%	498 56.1%
History of drug or alcohol problem (Count of Participants)
Count of Participants [Participants]	40 15.5%	55 15.1%	27 10.2%	122 13.8%

Outcome Measures

1. Primary Outcome

Title	7-day Point Prevalence of Abstinence
Description	7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
Time Frame	6-month

Outcome Measure Data

Analysis Population Description

Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)

Arm/Group Title	Bupropion + Motivational Emails	Motivational Emails	Varenicline + Motivational Emails
Arm/Group Description	participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks	participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
Measure Participants	185	137	165
Count of Participants [Participants]	45 17.4%	22 6%	50 18.9%

2. Primary Outcome

Title	Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
Description	Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed
Time Frame	End of Treatment

Outcome Measure Data

Analysis Population Description

total number of eligible participants in study

Arm/Group Title	All Eligible Participants
Arm/Group Description	All participants who were eligible to receive medication
Measure Participants	893
Count of Participants [Participants]	588 227.9%

Adverse Events

Adverse Event Reporting Description	Serious and other [non-serious] adverse events were not collected or assessed as part of the study
Arm/Group Title	Bupropion + Motivational Emails		Motivational Emails		Varenicline + Motivational Emails
Arm/Group Description	participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks. bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks motivational emails : brief motivational emails, sent weekly for 12 weeks		participants receive weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks		participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks. motivational emails : brief motivational emails, sent weekly for 12 weeks varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
All Cause Mortality
	Bupropion + Motivational Emails		Motivational Emails		Varenicline + Motivational Emails
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Bupropion + Motivational Emails		Motivational Emails		Varenicline + Motivational Emails
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Bupropion + Motivational Emails		Motivational Emails		Varenicline + Motivational Emails
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.