Effects of Nicotine on Areas of Impaired and Preserved Functioning in Schizophrenia

NCT01034085 | Completed

• 2 other identifiers: 99990944509-DA-N445
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Some people with schizophrenia have problems with their working memory and paying attention for extended periods. These difficulties cannot be treated with antipsychotic medications or with many standard therapies.
• The prevalence of cigarette smoking among individuals with schizophrenia is about three times higher than in the general population. Research has shown that nicotine, the addictive component found in cigarettes, can help improve attentional and working memory performance. Researchers are interested in learning more about whether there may be an overlap in the cognitive functions beneficially affected by nicotine and areas of dysfunction in individuals with schizophrenia. Objectives:
• To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication.
• To gather preliminary data on genetics that may account for individual and group differences in the performance effects of nicotine. Eligibility: \- Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55 years of age who are either healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder. Design:
• The study will require five visits to the research center, with an initial screening visit, a training session, and three test sessions. Ideally, all visits will occur 1 week apart.
• Training session: Participants will receive training on the types of computerized cognitive and attentional behavior tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use.
• Test sessions: Participants will be assigned to random groups and will complete tests that assess cognitive performance (a) while maintaining their usual smoking behavior, (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch, and (c) under the influence of a standard nicotine patch. The order of these sessions will be different for individual participants.
• Participants will provide blood samples throughout the research study for evaluation purposes.

Conditions

Nicotine Dependence; Schizophrenia

Keywords

Nicotine; Schizophrenia; Cognition; Genes; Smoking; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Cognitive task performance

Secondary Outcomes (1)

• Measures of subjective state plasma concentrations of nicotine and metabolites genoytype with regards to genes that may affect nicotine response.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants:
• Age 18 through 55. The aim is to minimize population inhomogeneity related to cognitive decline due to normal aging.
• Smoker of 5 or more cigarettes, cigarillos or cigars per day, on 5 or more days/week, for at least the last 12 months
• Normal or corrected to normal visual acuity (at least 20/100).
• DSM-IV diagnosis of schizophrenia or schizoaffective disorder
• Ability to give written informed consent
• Four weeks of stable pharmacological treatment (same psychiatric medication at same dose)

You may not qualify if:

• All participants:
• History of myocardial infarction, heart failure, angina, stroke or severe arrhythmias, EKG abnormalities as specified under Screening methods
• Uncontrolled high blood pressure (resting systolic above 150 or diastolic above 90 mm Hg)
• Neurological conditions such as stroke, seizures, dementia or organic brain syndrome
• Any condition likely to impair cognitive function such as mental retardation, attention deficit disorder or severe pharmacological sedation
• Treatment for tobacco dependence in the last four months
• Alcohol or substance abuse or dependence other than nicotine within the last 12 months
• Pregnancy, verified by urine pregnancy test for females at first visit and in the beginning of each of the two patch administration sessions
• Lactating
• Current psychiatric Axis I disorder or Axis II schizophrenia spectrum disorder, verified by Structured Clinical Interview for DSM-IV (SCID)
• Treated with benztropine (a nicotinic and muscarinic antagonist) or with an acetylcholine esterase inhibitor currently or within the last four weeks

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue

Catonsville, Maryland, 21228, United States

Location

Related Publications (3)

• Adams CE, Stevens KE. Evidence for a role of nicotinic acetylcholine receptors in schizophrenia. Front Biosci. 2007 May 1;12:4755-72. doi: 10.2741/2424.

  PMID: 17485411 BACKGROUND

• Apud JA, Weinberger DR. Treatment of cognitive deficits associated with schizophrenia: potential role of catechol-O-methyltransferase inhibitors. CNS Drugs. 2007;21(7):535-57. doi: 10.2165/00023210-200721070-00002.

  PMID: 17579498 BACKGROUND

• Arinami T, Ishiguro H, Onaivi ES. Polymorphisms in genes involved in neurotransmission in relation to smoking. Eur J Pharmacol. 2000 Dec 27;410(2-3):215-226. doi: 10.1016/s0014-2999(00)00816-5.

  PMID: 11134671 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Schizophrenia; Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Elliot Stein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: June 2, 2009
• Study Completion: June 11, 2013
• Last Updated: April 5, 2018

Record last verified: 2013-06-11

Locations

US (1)