Nicotine Dependence
Conditions
Brief summary
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
Detailed description
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.
Interventions
DRUGnicotine patch
used according to FDA package label
DRUGnicotine lozenge
used according to FDA-approved package directions
DRUGnicotine patch + nicotine lozenge
dosage of both according to FDA-approved dosing schedule
DRUGbupropion
dosage according to FDA-approved instructions
dosage according to FDA approved standard instructions
DRUGplacebo
dosage same as active drug conditions
Sponsors
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments
Exclusion criteria
* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 6 months post quit date | Smoking status was assessed both as 7-day point-prevalence abstinence (Have you smoked at all, even a puff, in the last 7 days?) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Patch nicotine patch alone treatment for nicotine dependence. | 262 |
| Nicotine Lozenge nicotine lozenge alone treatment | 260 |
| Nicotine Patch + Lozenge nicotine patch + lozenge combination treatment | 267 |
| Bupropion bupropion alone treatment | 264 |
| Bupropion + Nicotine Lozenge bupropion + nicotine lozenge combination treatment | 262 |
| Placebo Control placebo control (no active medication) treatment | 189 |
| Total | 1,504 |
Baseline characteristics
| Characteristic | Nicotine Lozenge | Nicotine Patch + Lozenge | Bupropion | Nicotine Patch | Bupropion + Nicotine Lozenge | Placebo Control | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 8 Participants | 10 Participants | 6 Participants | 10 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 256 Participants | 262 Participants | 256 Participants | 252 Participants | 256 Participants | 179 Participants | 1461 Participants |
| Age Continuous | 45.3 years STANDARD_DEVIATION 10.4 | 44.2 years STANDARD_DEVIATION 11.1 | 43.9 years STANDARD_DEVIATION 11.7 | 44.9 years STANDARD_DEVIATION 11.6 | 45.3 years STANDARD_DEVIATION 10.4 | 43.1 years STANDARD_DEVIATION 11.4 | 44.7 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 260 participants | 267 participants | 264 participants | 262 participants | 262 participants | 189 participants | 1504 participants |
| Sex: Female, Male Female | 151 Participants | 153 Participants | 154 Participants | 153 Participants | 154 Participants | 111 Participants | 876 Participants |
| Sex: Female, Male Male | 109 Participants | 114 Participants | 110 Participants | 109 Participants | 108 Participants | 78 Participants | 628 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 207 / 262 | 214 / 260 | 227 / 267 | 195 / 264 | 217 / 262 | 129 / 189 |
| serious Total, serious adverse events | 5 / 262 | 5 / 260 | 5 / 267 | 8 / 264 | 6 / 262 | 6 / 189 |
Outcome results
Primary
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
Smoking status was assessed both as 7-day point-prevalence abstinence (Have you smoked at all, even a puff, in the last 7 days?) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).
Time frame: 6 months post quit date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Patch | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 90 participants with<10 ppm exhaled CO |
| Nicotine Lozenge | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 87 participants with<10 ppm exhaled CO |
| Nicotine Patch + Lozenge | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 107 participants with<10 ppm exhaled CO |
| Bupropion | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 84 participants with<10 ppm exhaled CO |
| Bupropion + Nicotine Lozenge | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 87 participants with<10 ppm exhaled CO |
| Placebo Control | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | 42 participants with<10 ppm exhaled CO |