Phase 4
N=126
Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01048944 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: 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. — .055; .224; .234; -.094 Change in log EEG [microvolts squared] — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupropion SR (Drug); Nicotine Patch (Drug); Placebo Patch and Placebo Pill (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern Illinois University Carbondale
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
.055; .224; .234; -.094; .194; .198 | <0.05 sig |
| PRIMARY Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence |
-.006; .045; .094; -.045; -.187; -.199 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01048944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.