Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Gilbert, Southern Illinois University Carbondale
ClinicalTrials.gov Identifier:
NCT01048944
First received: January 13, 2010
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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 SR, 2) nicotine patch, or 3) placebo pills and patches 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.


Condition Intervention Phase
Nicotine Dependence
Drug: Bupropion SR
Drug: Nicotine
Drug: Placebo pill and Placebo Patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: NRT & Bupropion Mechanisms of Effectiveness in Smokers: Phase IV Trial

Resource links provided by NLM:


Further study details as provided by Southern Illinois University Carbondale:

Primary Outcome Measures:
  • withdrawal symptom severity [ Time Frame: 67 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biobehavioral brain mood attention factors [ Time Frame: 67 days ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: June 2005
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion SR
150 mg bid bupropion SR
Drug: Bupropion SR
150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.
Other Name: ZybanSR
Active Comparator: Nicotine Patch
21mg, 14mg, 7mg
Drug: Nicotine
Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days
Other Name: NicodermCQ
Placebo Comparator: Placebo Patch and Placebo Pill
Placebo patch same size as active patches
Drug: 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.
Other Name: Placebo
No Intervention: Delayed-quit control
Smoke for 67 days while others have quit, then quit.

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) a placebo. 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 pill + placebo patch; 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048944

Locations
United States, Illinois
Southern Illinois University
Carbondale, Illinois, United States, 62901-6502
Sponsors and Collaborators
Southern Illinois University Carbondale
Investigators
Principal Investigator: David G Gilbert, PhD Southern Illinois University Carbondale
  More Information

No publications provided

Responsible Party: David Gilbert, Professor of Psychology, Southern Illinois University Carbondale
ClinicalTrials.gov Identifier: NCT01048944     History of Changes
Other Study ID Numbers: NIH/NIDA-2R01DA012289, 2R01DA012289
Study First Received: January 13, 2010
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University Carbondale:
Electroencephalography
nicotine
bupropion
attention
drug withdrawal symptoms

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014