Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
Information source: Southern Illinois University Carbondale
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nicotine Dependence
Intervention: Bupropion SR (Drug); Nicotine Patch (Drug); Placebo Patch and Placebo Pill (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Southern Illinois University Carbondale Official(s) and/or principal investigator(s): David G Gilbert, PhD, Principal Investigator, Affiliation: Southern Illinois University Carbondale
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.
Clinical Details
Official title: NRT & Bupropion Mechanisms of Effectiveness in Smokers: Phase IV Trial
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: 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.Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence
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.)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Southern Illinois University, Carbondale, Illinois 62901-6502, United States
Additional Information
Starting date: June 2005
Last updated: November 18, 2014
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