TOBACCO USE CESSATION
Conditions
Brief summary
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.
Detailed description
Please see brief summary.
Interventions
DRUGStandard Patch Treatment
8-weeks of nicotine patch + 16-weeks of placebo
DRUG24-weeks of nicotine patch
24-weeks of 21mg nicotine patch
Sponsors
National Cancer Institute (NCI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment. 2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study. 3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.
Exclusion criteria
1. Women who are pregnant, planning a pregnancy, or lactating. 2. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes. 3. Current treatment of cancer or diagnosed with cancer in the past 6 months 4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines). 5. Current use of TN or other forms of NRT. 6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Verified 7-day Point Prevalence Abstinence | End of Treatment (week 24) | To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited using mass media advertising from the the Greater Philadelphia area from June 2004 to April 2008.
Pre-assignment details
Once participants were enrolled and were eligible at the medical screening visit they were randomized to receiving either 8 weeks of 21 mg nicotine patch or 6 months of 21 mg nicotine patch treatment
Participants by arm
| Arm | Count |
|---|---|
| Extended Patch Treatment Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions. | 282 |
| Standard Patch Treatment Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch. | 286 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 1 |
| Overall Study | Withdrawal by Subject | 73 | 80 |
Baseline characteristics
| Characteristic | Standard Patch Treatment | Extended Patch Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 286 Participants | 281 Participants | 567 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 10.4 | 44.8 years STANDARD_DEVIATION 10.2 | 44.8 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 286 participants | 282 participants | 568 participants |
| Sex: Female, Male Female | 129 Participants | 125 Participants | 254 Participants |
| Sex: Female, Male Male | 157 Participants | 157 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 282 | 0 / 286 |
| serious Total, serious adverse events | 0 / 282 | 1 / 286 |
Outcome results
Primary
Biochemically Verified 7-day Point Prevalence Abstinence
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
Time frame: End of Treatment (week 24)
Population: Intention to Treat analysis (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Patch Treatment | Biochemically Verified 7-day Point Prevalence Abstinence | 89 Participants |
| Standard Patch Treatment | Biochemically Verified 7-day Point Prevalence Abstinence | 58 Participants |