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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
University of Maryland |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01037075 |
Purpose
Background:
Objectives:
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:
| Condition |
|---|
|
Schizophrenia Drug Abuse/Dependency |
| Study Type: | Observational |
| Official Title: | Influence of Nicotine on Cognitive Function in Schizophrenic Patients With and Without Comorbid Drug Dependence |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2006 |
Objective:
Specific aim 1: To test the hypothesis that individuals with comorbid schizophrenia and drug dependence will show impaired neurocognitive functions in anticipatory learning of eyetracking, attention, and memory performance compared to healthy controls subjects.
Specific aim 2: To test the hypothesis that nicotine will dose-dependently improve anticipatory learning of eyetracking, attention, and memory performance in individuals with comorbid schizophrenia and substance dependence.
Study Population:
Male and nonpregnant-female smokers 18 to 55 years of age, from the following subject groups: (1) patients with a DSM IV diagnosis of schizophrenia (2) patients with dual DSM IV diagnoses of schizophrenia and heroin and/or cocaine dependence or abuse, or on methadone or beprenorphine maintenance and (3) healthy individuals with no family history of psychotic illness.
Design:
This study will be a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants will have four visits. After the training session, participants will be administered one dose (0, 1 or 2 mg) of nicotine nasal spray during each of the 3 experimental sessions. The dose will be given 5 minutes prior to the cognitive task batteries.
Outcome Measures:
Vital signs, moods, and performance on tasks assessing eye movement (initiation latency, initiation acceleration, closed-loop pursuit gain), attention (Continuous Performance and Digit Symbol Substitution Tasks), and memory (delayed recognition and nback).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
All participants must meet the following criteria:
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.
EXCLUSION CRITERIA:
Comprehensive medical history:
-Exclusions: Heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
Drug Use Survey
All subjects:
Structured Clinical Interview for DSM-IV
-Healthy controls: exclude if any current psychiatric disorder
Urine pregnancy for females:
-Exclude if positive.
Contacts and Locations| Contact: MMG Recruiting | (800) 535-8254 | researchstudies@mail.nih.gov |
| United States, Maryland | |
| University of Maryland, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201-1595 | |
| National Institute on Drug Abuse, Biomedical Research Center (BRC) | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Sub-Investigator: Mathew's Media Group Recruiting For more information contact | |
| VA Hospital, Baltimore | Recruiting |
| Baltimore, Maryland, United States | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Matthews Media Group | Recruiting |
| Rockville, Maryland, United States, 20850 | |
More Information
| ClinicalTrials.gov Identifier: | NCT01037075 History of Changes |
| Obsolete Identifiers: | NCT00686153 |
| Other Study ID Numbers: | 999906400, 06-DA-N400 |
| Study First Received: | December 18, 2009 |
| Last Updated: | December 31, 2011 |
| Health Authority: | United States: Federal Government |
|
Schizophrenia Dual Diagnosis Nicotine Nasal Spray Drug Abuse/Dependence Cognitive Processes |
|
Substance-Related Disorders Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |