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Bupropion SR Plus Counseling for Smoking Cessation

A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01621009
Enrollment
463
Registered
2012-06-15
Start date
2001-01-31
Completion date
2003-10-31
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Tobacco Dependence

Keywords

smoking cessation medications, smoking cessation counseling

Brief summary

The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.

Interventions

DRUGActive bupropion + counseling

Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks. Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.

DRUGActive bupropion, No counseling

Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day. Counseling: No cessation counseling, only medication checks

DRUGPlacebo medication + counseling

Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day. Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.

DRUGPlacebo medication, No counseling

Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day. Counseling: No counseling, just medication checks

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Smoke 10 or more cigarettes per day * Expired carbon monoxide (CO) level greater than 9 parts per million (ppm) * Motivated to quit smoking (score of 3 on 4-point self-report scale) * Willing to fulfill study requirements

Exclusion criteria

* Carbon monoxide breath test score below 9 ppm * Serious psychopathology (bipolar disorder, psychosis) * Center for Epidemiologic Studies Depression Scale CES-D)score over 16 * Contraindications for use of bupropion * History of seizure disorder * History of eating disorder * Current heavy drinking * Risk of pregnancy * Current breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
7-day Point Prevalence Abstinence From Smoking at 6 Months6 monthsNo smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Countries

United States

Participant flow

Recruitment details

Participants recruited from Madison, WI area through TV, radio, newspaper advertisements from January, 2001 to October 2002

Pre-assignment details

Participants were 1) phone screened, 2) invited to group orientation where signed consent was obtained, and 3) completed CO testing and office visit for physical exam. Participants were considered enrolled after passing all 3 steps and randomization occurred at enrollment.

Participants by arm

ArmCount
Active Bupropion + Counseling
Active bupropion SR plus eight 10-minute individual counseling sessions.
113
Active Bupropion , No Counseling
Active bupropion, No counseling, only medication checks
116
Placebo Medication + Counseling
Placebo bupropion plus eight 10-minute individual counseling sessions
121
Placebo Medication, No Counseling
Placebo bupropion, No counseling, just medication checks
113
Total463

Baseline characteristics

CharacteristicTotalPlacebo Medication, No CounselingPlacebo Medication + CounselingActive Bupropion , No CounselingActive Bupropion + Counseling
7-day point prevalence abstinence
Abstinent
66 participants14 participants15 participants16 participants21 participants
7-day point prevalence abstinence
Not Abstinent
397 participants99 participants106 participants100 participants92 participants
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
463 Participants113 Participants121 Participants116 Participants113 Participants
Age, Continuous38.76 years
STANDARD_DEVIATION 12.16
39.42 years
STANDARD_DEVIATION 11.34
37.82 years
STANDARD_DEVIATION 12.82
41.03 years
STANDARD_DEVIATION 12.64
36.76 years
STANDARD_DEVIATION 11.39
Region of Enrollment
United States
463 participants113 participants121 participants116 participants113 participants
Sex: Female, Male
Female
233 Participants61 Participants63 Participants57 Participants52 Participants
Sex: Female, Male
Male
230 Participants52 Participants58 Participants59 Participants61 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
66 / 23494 / 229
serious
Total, serious adverse events
0 / 2340 / 229

Outcome results

Primary

7-day Point Prevalence Abstinence From Smoking at 6 Months

No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Time frame: 6 months

Population: Full intent-to-treat sample

ArmMeasureValue (NUMBER)
Bupropion + Counseling7-day Point Prevalence Abstinence From Smoking at 6 Months21 Number of abstinent participants
Bupropion, No Counseling7-day Point Prevalence Abstinence From Smoking at 6 Months16 Number of abstinent participants
Placebo + Counseling7-day Point Prevalence Abstinence From Smoking at 6 Months15 Number of abstinent participants
Placebo, No Counseling7-day Point Prevalence Abstinence From Smoking at 6 Months14 Number of abstinent participants
p-value: >0.0595% CI: [0.78, 3.36]Regression, Logistic
p-value: >0.0595% CI: [0.52, 2.44]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026