Influence of Nicotine on Cognitive Function in Schizophrenic Patients With and Without Comorbid Drug Dependence

NCT01037075 | Completed

• 2 other identifiers: 99990640006-DA-N400
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Individuals with schizophrenia have a significantly higher tendency to develop substance abuse or dependence than the general population. For instance, people with schizophrenia smoke much more than the general population, and many are dependent on street drugs such as cocaine and heroin. However, these individuals are rarely included in research studies that might provide more information about treatments for both schizophrenia and substance abuse.
• Strong evidence suggests that schizophrenia and substance dependence have similar effects on the brain, affecting attention, memory, and eye movement. Other research indicates that schizophrenia and substance dependence affect the same parts of the dopamine system, contributing to problems in brain function that require treatment. These new developments provide a strong rationale to study the combination of schizophrenia and substance dependence.
• Nicotine may help improve brain function and thinking in individuals with both schizophrenia and drug dependence. Some of the thinking and memory problems experienced by these individuals can be treated with nicotine. However, more research is needed to determine exactly how nicotine affects individuals with both schizophrenia and drug dependence. Objectives:
• To determine whether individuals with schizophrenia and drug dependence show impairment in tests of eye tracking, attention, and memory compared with healthy control subjects.
• To evaluate the effect of nicotine on eye tracking, attention, and memory in individuals with both schizophrenia and substance dependence. Eligibility: \- Current smokers (at least 10 cigarettes per day for the past year) between 18 and 55 years of age who (1) have been diagnosed with schizophrenia/schizoaffective disorder, (2) have been diagnosed with schizophrenia/schizoaffective disorder and are currently using heroin and/or cocaine, or (3) are healthy individuals with no family history of psychotic illness. Design:
• The study will consist of one training session and three testing sessions. Each session will last about 2 hours.
• The training session will introduce participants to the study tests and evaluate their tolerance of the nicotine nasal spray used in the study. Participants who cannot tolerate the higher dose of the spray will not continue in the study.
• At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine.
• During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate attention, memory, and other thinking tasks.

Conditions

Schizophrenia; Drug Abuse/Dependency

Keywords

Schizophrenia; Dual Diagnosis; Nicotine Nasal Spray; Drug Abuse/Dependence; Cognitive Processes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants must meet the following criteria:
• age 18 60
• smoke 10 or more cigarettes/day for at least the past year
• Experimental groups 1 and 2, additional criteria:
• DSM-IV diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other MPRC screening protocols).
• Experimental group 2, additional criteria:
• DSM-IV diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.

You may not qualify if:

• Comprehensive medical history:
• Drug Use Survey
• All subjects:
• Exclude if treatment for tobacco dependence during the previous 6 months.
• Healthy controls and schizophrenic patients without comorbid drug abuse or dependence: Exclude if history alcohol or other substance dependence ever, or alcohol or other substance abuse in the past year. Verify abstinence from controlled substances with urine screen (Iscreen). Participants in the above 2 groups who are positive for any illicit drug (with the exception of marijuana) will be excluded.
• Structured Clinical Interview for DSM-IV
• Healthy controls: exclude if any current psychiatric disorder
• Urine pregnancy for females:
• Exclude if positive.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• University of Maryland, College Park: collaborator

Study Sites (2)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Matthews Media Group

Rockville, Maryland, 20850, United States

Location

Related Publications (3)

• Avila MT, Sherr JD, Hong E, Myers CS, Thaker GK. Effects of nicotine on leading saccades during smooth pursuit eye movements in smokers and nonsmokers with schizophrenia. Neuropsychopharmacology. 2003 Dec;28(12):2184-91. doi: 10.1038/sj.npp.1300265.

  PMID: 12968127 BACKGROUND

• Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.

  PMID: 11306219 BACKGROUND

• Berman SM, Martinez RA, Noble EP. Familial alcoholism and ERPs: differences in probability sensitivity? Alcohol Alcohol. 1993 Nov;28(6):695-707.

  PMID: 8147978 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Carol Myers, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: May 14, 2006
• Study Completion: January 22, 2013
• Last Updated: December 16, 2019

Record last verified: 2013-01-22

Locations

US (2)