This study investigates the effects of various smoking cessation therapies on people with and without a history of psychiatric conditions

• Conditions: icotine Addiction with the desire to quit smoking; MedDRA version: 14.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2010-022914-15-ES
• Lead Sponsor: Pfizer, S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

The following is an excerpt of the most critical Inclusion criteria in protocol A3051123. For a complete listing of all Inclusion criteria please refer to sections 4.1 and 4.2 of the protocol.

Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the psychiatric or non psychiatric arm of the study:
1. Male or female cigarette smokers, 18 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
2. Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
3. Females who are not of childbearing potential (ie, who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are of childbearing potential may be included provided that they are not pregnant, not nursing, and meet all of the following criteria:
? Are instructed and agree to avoid pregnancy through 30 days after the last dose of study medication;
? Have a negative pregnancy test (beta hCG) at Screening and Baseline and
? Agree to use at least one of the birth control methods listed below:
? An oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (eg, Norplant), or an injectable contraceptive (eg, Depo Provera) for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication or;
? A double barrier method of contraception, eg, condom and diaphragm with spermicide while participating in the study through at least 30 days after the last dose of study medication or abstinence.
4. A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Additional Inclusion Criteria for Neuropsychiatric Cohort:
In addition to the criteria above, subjects to be included in the Neuropsychiatric cohort must also meet the following: All subjects will be screened for Axis I and II diagnosis (current and/or past) using DSM IV TR criteria based on clinical assessment and confirmed by SCID (administered by a clinician or a qualified person trained in clinical mental health, ie; a PhD level clinical psychologist, or an individual with master level training in related areas [masters level psychologist, social work] who have been trained to use the SCID ). A ?current? diagnosis is defined as the subject meeting the established criteria in the prior month. A ?past? diagnosis is also the same as a ?lifetime? diagnosis where applicable. A past diagnosis can have occurred anytime in the past medical history. The four major diagnostic groups comprising the neuropsychiatric cohort are: Psychotic, Affective, Anxiety and Personality Disorders. The four diagnostic groups are further described below. Subjects will be included in the psychiatric cohort, if they are considered clinically stable and meet criteria, either current or lifetime diagnosis, for one or more of the DSM IV diagnoses listed below and have met diagnostic criteria before the initiation of study treatment.
a. Psychotic Disorders limited to:
? Schizophrenia;
? Schizoaffective.
b. Affective Disorders limited to:
? Major Depression;
c. Anxiety Disorders limited to

Exclusion Criteria

The following is an excerpt of the most critical Exclusion criteria in protocol A3051123. For a complete listing of all Exclusion criteria please refer to sections 4.1 and 4.2 of the protocol.

Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
6. Subjects with a past or current diagnosis of one of the following disorders:
a. Psychotic Disorders:
? Schizophreniform;
? Delusional Disorder;
? Psychotic Disorder NOS.
b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders;
c. All Substance Induced Disorders (Other than nicotine);
d. All Factitious Disorders;
e. All Dissociative Disorders;
f. All Impulse Control Disorders;
g. Evidence of substance abuse/misuse or dependence severe enough to compromise the subject?s ability to comply with the study requirements;
h. Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject?s ability to comply with the study requirements.
7. Subjects with an Axis I diagnosis according to DSM IV TR criteria who have a rating of 5 or higher on the Clinical Global Impression Severity (CGI S).
8. Subjects who are believed to have a suicidal risk at screening, baseline, or after assessment by a qualified MHP-(Psychiatrist) if a risk assessment interview was required after screening or baseline using the Columbia Suicide Severity Rating Scale (C SSRS).
? Suicide ideation associated with actual intent and/or plan in the past year: Yes answers on item 5 of the C SSRS.
? Previous history of suicide behaviors in the past year.
9. Subjects who in the opinion of the Investigator display self injuring behaviors.
10. Subjects with a positive urine drug screen at screening or baseline.
11. Subjects taking an investigational drug within 30 days before the Baseline visit and at anytime during the study period.
12. Subjects who have taken varenicline, bupropion, or NRT within 30 days prior to Baseline visit.
13. Subjects for whom treatment with bupropion is not appropriate:
? Subjects with seizure disorder;
? Subjects undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines);
? Subjects with current or prior diagnosis of anorexia or bulimia nervosa;
? Subjects who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen days (prior to the Baseline visit);
? Subjects who are taking the following narrow therapeutic range medications which are metabolized by CYP2D6; desipramine, nortriptyline, Type 1C antiarrhythmics (eg, propafenone, flecainide), thioridazine.
14. Subjects with severe chronic obstructive pulmonary disease (COPD) defined as any subject who fulfills any of the following criteria:
? History of repeated exacerbations of COPD (greater than or equal to 3 in 3 years);
? Requires systemic corticosteroid maintenance (eg, oral prednisolone) for management of chronic symptoms;
? Is maintained on oxygen therapy for management of chronic symptoms.
15. Subjects with clinically significant cardiovascular disease in the past 2 months. Examples of clinically significant cardiovascular disease include:
? Myocardial infarction;
? Coronary artery bypass graft (CABG);
? Percutaneous transluminal coronary angioplasty (PTCA);
? Severe or unstable angina;
? A serious arrhythmia;
? Clinically significant ECG conduction abnormalities;
? Hospitalizations for heart failure.
16. Subjects with clinically significant cerebrovascular disease in the past 2 months. Examples

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified