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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01048944 |
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Date of registration:
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13/01/2010 |
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Primary sponsor: |
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Public title:
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Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
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Scientific title:
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NRT & Bupropion Mechanisms of Effectiveness in Smokers: Phase IV Trial |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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125 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01048944 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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David G Gilbert, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Southern Illinois University Carbondale |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nicotine Dependence
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Intervention(s)
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Drug: Bupropion SR
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Drug: Nicotine
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Drug: Placebo pill and Placebo Patch
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Other: Delayed-Quit Control
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Primary Outcome(s)
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withdrawal symptom severity
[Time Frame: 67 days]
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Secondary Outcome(s)
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biobehavioral brain mood attention factors
[Time Frame: 67 days]
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Secondary ID(s)
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2R01DA012289
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NIH/NIDA-2R01DA012289
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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