Tobacco Use Disorder
Conditions
Keywords
light smokers, smoking cessation treatment programs
Brief summary
The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.
Detailed description
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.
Interventions
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
DRUGbupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
BEHAVIORALMedication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
BEHAVIORALMayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
DRUGplacebo patch
placebo patch containing no nicotine
placebo pills
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Light smokers (6-15 cigarettes per day Inclusion Criteria: Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)
Exclusion criteria
Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Treatment Sessions Attended | 52 weeks | Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing. |
Secondary
| Measure | Time frame |
|---|---|
| Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type. | 52 weeks |
Countries
United States
Participant flow
Recruitment details
The sample consists of 260 self-referred lighter smokers to an urban university setting. The first participant was enrolled in February 2005, and the last follow-up was completed in March 2008. A total of 302 met confirmatory screening criteria, and 260 were enrolled.
Pre-assignment details
An in-person confirmatory screening interview consisted of a medical examination, structured psychological interview (Mini International Neuropsychiatric Interview; Sheenan et al., 1997), and biochemical testing (i.e., carbon monoxide reading of expired air \[CO\], blood alcohol concentration,and urine drug test).
Participants by arm
| Arm | Count |
|---|---|
| 1: Bup+MM bupropion and MM with placebo patch | 70 |
| 2 Bup+Mayo bupropion and Mayo counseling with placebo patch. | 63 |
| 3 Patch+MM patch and MM with placebo pills | 62 |
| 4 Patch+Mayo patch and Mayo counseling with placebo patch | 65 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 11 | 13 | 12 |
Baseline characteristics
| Characteristic | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+MM | 4 Patch+Mayo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12.5 | 42.4 years STANDARD_DEVIATION 12.6 | 45.8 years STANDARD_DEVIATION 12.6 | 43.1 years STANDARD_DEVIATION 11.3 | 43.3 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 70 participants | 63 participants | 62 participants | 65 participants | 260 participants |
| Sex: Female, Male Female | 44 Participants | 31 Participants | 35 Participants | 38 Participants | 148 Participants |
| Sex: Female, Male Male | 26 Participants | 32 Participants | 27 Participants | 27 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 70 | 3 / 63 | 0 / 62 | 2 / 65 |
| serious Total, serious adverse events | 1 / 70 | 0 / 63 | 1 / 62 | 0 / 65 |
Outcome results
Primary
Percent Treatment Sessions Attended
Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1: Bup+MM | Percent Treatment Sessions Attended | 77.9 Percentage of attended tx. sessions | Standard Error 0.05 |
| 2 Bup+Mayo | Percent Treatment Sessions Attended | 85.9 Percentage of attended tx. sessions | Standard Error 0.04 |
| 3 Patch+mm | Percent Treatment Sessions Attended | 66.8 Percentage of attended tx. sessions | Standard Error 0.06 |
| 4 Patch+Mayo | Percent Treatment Sessions Attended | 66.6 Percentage of attended tx. sessions | Standard Error 0.06 |
Comparison: Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.p-value: <0.01795% CI: [0.77, 2.25]GEE model for repeated binary outcomes
Secondary
Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.
Time frame: 52 weeks
Population: PI is no longer with institution. All efforts have been exhausted to locate this data, but no data is available to be reported