The Effect of Nicotine on Arousal, Cognition and Social Cognition in Young and Elderly Healthy Subjects.

NCT01181934 | Completed Early Phase 1

• 1 other identifier: CR017251
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study in young and elderly healthy subjects will investigate the effect of nicotine on arousal, cognitive task and social cognition after acute dose administration.

Conditions

Schizophrenia; Cognition Disorders

Keywords

symptomatic treatment; cognition; cognitive deficits; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of nicotine on measures of arousal and event related potentials, especially the P50 auditory evoked potential, as well as standard cognitive tasks and social cognition.

  1 hour post dose

Secondary Outcomes (1)

• Nicotine exposure

  predose and 5 min post each dosing

Study Arms (3)

001

EXPERIMENTAL

A643 (nicotine) 1mg oromucosal nicotine spray- three times daily during each treatment period

Other: A643 (nicotine)

002

EXPERIMENTAL

A643 (nicotine) 2mg oromucosal nicotine spray- three times daily during each treatment period

Other: A643 (nicotine)

003

PLACEBO COMPARATOR

placebo placebo - three times daily during each treatment period

Drug: placebo

Interventions

A643 (nicotine) OTHER

2mg oromucosal nicotine spray- three times daily during each treatment period

002

placebo DRUG

placebo - three times daily during each treatment period

003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman between 18 and 30 years of age inclusive (Cohort 1 only)
• Man or woman between 60 and 75 years of age, inclusive (Cohort 2 only)
• Body mass index (BMI) between 18 and 35 kg/m2, inclusive (BMI = eight/height2)
• Women must be: postmenopausal (for at least 12 months), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control and must agree to continue to use the same method of contraception throughout the study
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (each study period)
• Men must agree to use a condom at each sexual intercourse and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration

You may not qualify if:

• Female volunteers who are pregnant or breastfeeding
• Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable. Values of alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 2 fold Upper Limit of Normal will be allowed
• Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening
• History of epilepsy or fits or unexplained black-outs
• Current dangerous or aggressive behavior
• Clinically significant history of drug and/or food allergies
• Recent history (within previous 6 months) of alcohol or drug abuse
• Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant should exclude the subject (Subjects with well-controlled hypertension will be allowed to participate)
• Significant history of or current psychiatric or neurological illness
• Smoking cigarettes (or equivalent) or the use of nicotine based products, within 3 months prior to study drug administration. Current use of any medication for smoking cessation such as nicotine replacement therapy, bupropion or varenicline
• Positive urine screen for drugs of abuse at screening or admission

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: May 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03