Trials Sponsors Conditions Drugs Pricing

Conditions

Nicotine Dependence

Keywords

CRH AntagonistNicotineNicotine DependenceSmokingStress

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Daily smokers for at least one year; smoke at least 10 cigarettes per day; smoke first cigarette of day within one hour of waking as recorded on Fagerstrom Test of Nicotine Dependence (FTND).
Currently wish to quit smoking. Stage of Change (Prochaska and DiClemente, 1983) will be assessed for each participant and those who are in the contemplation and planning stages will be included in the study.
Urinary continine level greater than or equal to 100 ng/ml (NicAlert reading greater than or equal to 3) at screening.
Men and women, ages 18 to 55 years. Justification: Many cognitive processes change with age. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. As this study includes fMRI scanning, older individuals, defined as those over 55, will be excluded as these age-related abnormalities may affect quality of imaging data.

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead

Related Publications (3)

Bandettini PA, Wong EC. A hypercapnia-based normalization method for improved spatial localization of human brain activation with fMRI. NMR Biomed. 1997 Jun-Aug;10(4-5):197-203. doi: 10.1002/(sici)1099-1492(199706/08)10:4/53.0.co;2-s.
PMID: 9430348BACKGROUND
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PMID: 3204199BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

Elliot Stein, Ph.D.
National Institute on Drug Abuse (NIDA)
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: NIH

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 19, 2012

Study Start

February 24, 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Employees of BristolMyersSquibb (BMS) or immediate family of BMS employees.
People who are currently participating in another clinical study in which they are exposed to an investigational or non-investigational drug or device; people who have ever participated in a trial involving pexacerfont or closely related compounds.
People who are unable or unwilling to participate in an MR scan, including those who are left-handed, have metallic objects in the body (pacemaker, plates, clips, pins, rods, joints, pellets, cochlear implants, etc.), have pronounced claustrophobia, or who are physically incompatible with the machine dimensions.\<TAB\>
Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months from the administration of last dose of study drug.
People who currently use any illicit drugs or whose urine tests positive for illegal drugs at screening. People with a past history of dependence to drugs or alcohol, or who currently meet DSM-IV criteria for alcohol abuse or dependence or who consume more than 15 alcoholic drinks per week during the past month.
People with evidence of thyroid disease by medical history, on screening physical exam or
laboratory tests with TSH greater than 1.6 times upper limit of normal.
People with a current seizure disorder or a significant history (as judged by the investigators) of a seizure disorder, other significant neurological disorders (e.g., Parkinson s Disease, multiple sclerosis, stroke, neurodegenerative disease, cerebral palsy) or severe head trauma, or CNS tumor.
People with current renal or liver disease including abnormal liver function tests (LFT s): greater than or equal to 2.5 times upper limit of normal, Bilirubin 2 times upper limit of normal, or abnormal renal function: serum creatinine greater than or equal to 2mg/dL.
People with a history of diabetes mellitus type I and II or gastric bypass or reduction surgery. Justification: illnesses that change metabolism or the absorption from the GI tract, would interfere with drug metabolism or absorption).
People with cardiovascular abnormalities including diastolic BP greater than 105; systolic BP greater than 180; QTc greater than 475 msec.
People with hematologic abnormalities at screening: Platelets less than or equal to75,000/mm(3), hemoglobin less than or equal to 9g/dL, neutrophils, absolute less than or equal to 1000/mm(3).
People with HIV infection Justification: HIV can have CNS sequelae, thus introducing unnecessary variability into the data. Assessment tool(s): HIV salivary test.
People with difficulty swallowing capsules.
+3 more criteria

Pexacerfont to Reduce Stress-induced Tobacco Craving

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record