Nicotine Dependence
Conditions
Keywords
Electroencephalography, nicotine, bupropion, attention, drug withdrawal symptoms
Brief summary
The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up. In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.
Detailed description
The first aim of this revised proposal is to accurately assess the duration and trajectories of smoking abstinence symptoms and associated biobehavioral indices across 66 days of quitting smoking in 3 different treatment groups: 1) bupropion SR (BUP), 2) transdermal nicotine patch (TNP), and 3) placebo patch plus placebo pill. Study sensitivity and accuracy will be maximized by using procedures designed to maximize abstinence and minimize study dropout. The second aim is to characterize brain and psychological mechanisms by which BUP and TNP promote abstinence. While the efficacies of BUP and TNP in promoting smoking abstinence have been repeatedly demonstrated, little is known about the mechanisms mediating this efficacy. The final primary goal of this competitive continuation proposal is to characterize individual differences in psychological and brain mechanisms mediating the beneficial effects of BUP and TNP on smoking abstinence and withdrawal symptoms. A secondary goal is to assess the ability of a battery of innovative brain and biobehavioral measures of attention and affect to predict relapse. To achieve these goals, the effects of quitting smoking with or without the help of TNP and BUP will be assessed intensively across 66 days of abstinence. Dependent measures will be mood, vigilance, attentional bias to smoking and emotional stimuli, and related physiological measures (resting EEG activation and activation asymmetry indices of affective states and traits, and event-related potential activity elicited by emotional and smoking stimuli). Smokers will be randomly assigned to one of three immediate-quit groups (N = 60 per group): (1) bupropion + placebo patch, (2) placebo pill + nicotine patch, and (3) placebo patch + placebo pill; or to a fourth (control) group (N = 40) that will quit after the final experimental session (after the other subjects have completed their 66-day\* abstinence period). Subjects in the 3 treatment groups and the control group will have the same set of biobehavioral measures assessed during the experimental sessions at the same points in time. It is hypothesized that BUP and TNP will have both common and unique mechanisms by which they reduce withdrawal symptoms and that gender and personality traits will moderate the effects of these treatments. (Note.\* To avoid final-session mood and arousal effects subjects will actually quit for 67 days, but biobehavioral measures will be collected on the 66th day of abstinence.)
Interventions
DRUGBupropion SR
150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
DRUGNicotine Patch
Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
DRUGPlacebo Patch and Placebo Pill
150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days. The placebo patches were given beginning 1st day cessation: 21 mg size (but actually placebo)/24 days, 14 mg size (actually placebo)/ 14 mg size (actually placebo) 14 days/, 7 mg size (actually placebo)/7 days
Sponsors
National Institute on Drug Abuse (NIDA)
Southern Illinois University Carbondale
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) diagnosis of nicotine dependence with psychological dependence * Smokes at least 10 cigarettes per day for the three months prior to enrollment * Currently seeking treatment for nicotine dependence * Medically healthy on the basis of physical examination and medical history, vital signs, * Females must use an effective method of contraception for the duration of the study
Exclusion criteria
* DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine * Current Axis I diagnosis or current treatment with psychotropic medications within the three months prior to enrollment * History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders * Currently seeking treatment for nicotine disorders * History of seizures or head trauma with loss of consciousness, brain contusion, or fracture * History of significant recent violent behavior * Blood pressure greater than 150/90 * History of eating disorders * History of allergic reaction to any of the study medications * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit | Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second \[cps\]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power \[microvolts squared\] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline. |
| Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Changes in log withdrawal symptoms from baseline through 66 days of abstinence | Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values. |
Countries
United States
Participant flow
Recruitment details
Recruitment: 9/01/06 to 9/01/11. Recruitment was throughout Carbondale and surrounding communities and occurred with newspaper ads, flyers, radio and television presentations. Recruitment was more challenging than expected because of the large time commitment and high prevalence of psychoactive medication and drug use (exclusionary criteria).
Pre-assignment details
After consent subjects and the completion of their first experimental session subjects were randomly assigned to one of 4 treatment arms: 197 signed the consent, 126 completed the first experimental session and were subsequently randomly assigned to a treatment condition.
Participants by arm
| Arm | Count |
|---|---|
| Bupropion SR 150 mg bid bupropion SR
Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. | 32 |
| Nicotine Patch 21mg, 14mg, 7mg
Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days | 38 |
| Placebo Patch and Placebo Pill Placebo patch same size as active patches
Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days. | 35 |
| Delayed-quit Control Smoke for 67 days while others have quit, then quit. | 21 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 8 | 10 | 10 | 2 |
Baseline characteristics
| Characteristic | Bupropion SR | Nicotine Patch | Placebo Patch and Placebo Pill | Delayed-quit Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 36 Participants | 34 Participants | 19 Participants | 119 Participants |
| Age, Continuous | 31.85 years STANDARD_DEVIATION 11.76 | 30.84 years STANDARD_DEVIATION 11 | 31.49 years STANDARD_DEVIATION 10.44 | 26.8 years STANDARD_DEVIATION 10.42 | 30.64 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment United States | 32 participants | 38 participants | 35 participants | 21 participants | 126 participants |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 18 Participants | 8 Participants | 58 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 17 Participants | 13 Participants | 68 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 | 21 / 32 | 22 / 38 | 19 / 35 | 6 / 21 |
| serious Total, serious adverse events | 0 / 32 | 0 / 38 | 0 / 35 | 0 / 21 |
Outcome results
Primary
Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.
Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second \[cps\]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power \[microvolts squared\] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.
Time frame: Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit
Population: For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Alpha-1 Power Pz | .139 Change in log EEG [microvolts squared] | Standard Error 0.099 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 66 Change in log Alpha-1 Power Pz | .339 Change in log EEG [microvolts squared] | Standard Error 0.099 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-2 Power Fz | .504 Change in log EEG [microvolts squared] | Standard Error 0.092 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-1 EEG Power Fz | .055 Change in log EEG [microvolts squared] | Standard Error 0.061 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Alpha-1 Power Pz | -.023 Change in log EEG [microvolts squared] | Standard Error 0.103 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-1 Power Fz | .232 Change in log EEG [microvolts squared] | Standard Error 0.055 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-1 EEG Power Fz | .431 Change in log EEG [microvolts squared] | Standard Error 0.075 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-1 EEG Power Fz | .194 Change in log EEG [microvolts squared] | Standard Error 0.068 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 45 Change in log Alpha-1 Power Pz | .292 Change in log EEG [microvolts squared] | Standard Error 0.099 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-2 Power Fz | .062 Change in log EEG [microvolts squared] | Standard Error 0.077 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-2 Power Fz | .251 Change in log EEG [microvolts squared] | Standard Error 0.087 |
| Nicotine Patch | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-2 Power Fz | .319 Change in log EEG [microvolts squared] | Standard Error 0.074 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-1 EEG Power Fz | .198 Change in log EEG [microvolts squared] | Standard Error 0.074 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-2 Power Fz | .248 Change in log EEG [microvolts squared] | Standard Error 0.081 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-1 EEG Power Fz | .407 Change in log EEG [microvolts squared] | Standard Error 0.081 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Alpha-1 Power Pz | .155 Change in log EEG [microvolts squared] | Standard Error 0.112 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Alpha-1 Power Pz | .301 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-2 Power Fz | .502 Change in log EEG [microvolts squared] | Standard Error 0.1 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-1 EEG Power Fz | .224 Change in log EEG [microvolts squared] | Standard Error 0.066 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-2 Power Fz | .150 Change in log EEG [microvolts squared] | Standard Error 0.094 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-2 Power Fz | .088 Change in log EEG [microvolts squared] | Standard Error 0.083 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-1 Power Fz | .249 Change in log EEG [microvolts squared] | Standard Error 0.06 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 66 Change in log Alpha-1 Power Pz | .459 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Bupropion SR | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 45 Change in log Alpha-1 Power Pz | .261 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-2 Power Fz | .205 Change in log EEG [microvolts squared] | Standard Error 0.1 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-1 EEG Power Fz | .234 Change in log EEG [microvolts squared] | Standard Error 0.066 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-1 EEG Power Fz | .258 Change in log EEG [microvolts squared] | Standard Error 0.074 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-1 Power Fz | .161 Change in log EEG [microvolts squared] | Standard Error 0.06 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-1 EEG Power Fz | .184 Change in log EEG [microvolts squared] | Standard Error 0.081 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-2 Power Fz | .249 Change in log EEG [microvolts squared] | Standard Error 0.083 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-2 Power Fz | .278 Change in log EEG [microvolts squared] | Standard Error 0.094 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-2 Power Fz | .278 Change in log EEG [microvolts squared] | Standard Error 0.094 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Alpha-1 Power Pz | .184 Change in log EEG [microvolts squared] | Standard Error 0.112 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Alpha-1 Power Pz | .276 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 45 Change in log Alpha-1 Power Pz | .259 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Placebo Patch and Placebo Pill | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 66 Change in log Alpha-1 Power Pz | .292 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-2 Power Fz | -.042 Change in log EEG [microvolts squared] | Standard Error 0.101 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-2 Power Fz | -.070 Change in log EEG [microvolts squared] | Standard Error 0.09 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Theta-1 EEG Power Fz | -.094 Change in log EEG [microvolts squared] | Standard Error 0.071 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Alpha-1 Power Pz | -.001 Change in log EEG [microvolts squared] | Standard Error 0.115 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-1 EEG Power Fz | -.026 Change in log EEG [microvolts squared] | Standard Error 0.087 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-1 Power Fz | -.032 Change in log EEG [microvolts squared] | Standard Error 0.065 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 66 Change in log Alpha-1 Power Pz | .017 Change in log EEG [microvolts squared] | Standard Error 0.116 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day 45 Change in log Alpha-1 Power Pz | .021 Change in log EEG [microvolts squared] | Standard Error 0.115 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-66 Change in log Theta-2 Power Fz | .001 Change in log EEG [microvolts squared] | Standard Error 0.107 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-45 Change in log Theta-2 Power Fz | .054 Change in log EEG [microvolts squared] | Standard Error 0.087 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-24 Change in log Theta-1 EEG Power Fz | -.060 Change in log EEG [microvolts squared] | Standard Error 0.08 |
| Delayed-quit Control | Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. | Day-3 Change in log Alpha-1 Power Pz | -.004 Change in log EEG [microvolts squared] | Standard Error 0.121 |
Comparison: Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).p-value: <0.05Mixed Models Analysis
Primary
Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values.
Time frame: Changes in log withdrawal symptoms from baseline through 66 days of abstinence
Population: Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Craving | -.006 log (base 10) units on a scale | Standard Error 0.038 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Craving | -.187 log (base 10) units on a scale | Standard Error 0.054 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Craving | -.273 log (base 10) units on a scale | Standard Error 0.047 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Craving | -.236 log (base 10) units on a scale | Standard Error 0.054 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Psych Withdrawal | .089 log (base 10) units on a scale | Standard Error 0.032 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Psych W | .065 log (base 10) units on a scale | Standard Error 0.031 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Psych Withdrawal | .008 log (base 10) units on a scale | Standard Error 0.031 |
| Nicotine Patch | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Psych Withdrawal | .068 log (base 10) units on a scale | Standard Error 0.037 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Psych W | .102 log (base 10) units on a scale | Standard Error 0.034 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Psych Withdrawal | .210 log (base 10) units on a scale | Standard Error 0.035 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Craving | -.199 log (base 10) units on a scale | Standard Error 0.06 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Psych Withdrawal | .032 log (base 10) units on a scale | Standard Error 0.041 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Psych Withdrawal | .063 log (base 10) units on a scale | Standard Error 0.034 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Craving | -.230 log (base 10) units on a scale | Standard Error 0.059 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Craving | -.201 log (base 10) units on a scale | Standard Error 0.052 |
| Bupropion SR | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Craving | .045 log (base 10) units on a scale | Standard Error 0.042 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Psych Withdrawal | .039 log (base 10) units on a scale | Standard Error 0.033 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Craving | -.132 log (base 10) units on a scale | Standard Error 0.05 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Craving | -.205 log (base 10) units on a scale | Standard Error 0.057 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Psych Withdrawal | .172 log (base 10) units on a scale | Standard Error 0.034 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Psych W | .076 log (base 10) units on a scale | Standard Error 0.033 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Psych Withdrawal | .029 log (base 10) units on a scale | Standard Error 0.039 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Craving | .094 log (base 10) units on a scale | Standard Error 0.04 |
| Placebo Patch and Placebo Pill | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Craving | -.045 log (base 10) units on a scale | Standard Error 0.057 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Craving | -.043 log (base 10) units on a scale | Standard Error 0.057 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Craving | -.075 log (base 10) units on a scale | Standard Error 0.065 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Craving | -.059 log (base 10) units on a scale | Standard Error 0.066 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Craving | -.045 log (base 10) units on a scale | Standard Error 0.046 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-3 Change in log Shiffman Psych Withdrawal | .016 log (base 10) units on a scale | Standard Error 0.039 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-66 Change in log Shiffman Psych Withdrawal | -.012 log (base 10) units on a scale | Standard Error 0.045 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-45 Change in log Shiffman Psych Withdrawal | -.017 log (base 10) units on a scale | Standard Error 0.038 |
| Delayed-quit Control | Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence | Day-24 Change in log Shiffman Psych W | -.025 log (base 10) units on a scale | Standard Error 0.038 |