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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01031433 |
Purpose
Background:
Objectives:
Eligibility:
- Current smokers (five or more cigarettes per day for at least 1 year) between 18 and 45 years of age who have been diagnosed with schizophrenia/schizoaffective disorder.
Design:
| Condition |
|---|
|
Nicotine Dependence |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality |
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2009 |
Objective:
Nicotine use is high in people with schizophrenia; however, interventions to aid in smoking cessation have not been overwhelmingly successful. Craving, particularly situational craving, is one reason people relapse. Craving paradigms in people with schizophrenia need to be optimized in order to test new treatments on craving measures in this population. Thus, the purpose of this study is to determine the feasibility and effects of virtual reality cues on craving intensity for smoking in patients with schizophrenia
Study population:
We will enroll 25 smokers with a DSM IV diagnosis of schizophrenia with the goal of obtaining a total of 16 completers.
Design:
This study uses a comparison-controlled, within-subject design. All subjects will undergo a baseline assessment and acclimation period and then participate in an experimental condition in which four cues will be presented in separate rooms in the VR program. These include two smoking cues and two neutral cues in four different rooms. A follow up session for craving and symptom assessments will occur one week after the experimental session.
Outcome Measures:
During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS), a four-item scale, and the Tobacco Craving Questionnaire-Short Form (TCQ-SF)will be administered to measure cigarette craving during the virtual reality session. At the end of each of the 4 cues (neutral, smoking cue with no interaction, smoking cue with interaction, neutral) participants will be asked about craving. The CCVAS will be projected into the VR environment and participants will respond via hand controller. To assess mood status, the Mood form will also be administered at baseline as well as at the end of each of the 4 cues. Before and after the experimental session participants will also be rated on the Brief Psychiatric Rating Scale (BPRS), Schedule for the Assessment of Negative Symptoms (SANS), side effects, and the State-Trait Anxiety Inventory (STAI). The Immersion Questionnaire and Imagery Realism Presence Questionnaire (PQ) will be given at the conclusion of the experimental session. During the experiment participants will be monitored for physiological reactivity (heart rate, blood pressure, and skin conductance response) to cues of smoking as well as neutral cues measured. Additionally, subjects will be assessed before and after the experimental session
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Stephanie M Feldman, L.C.S.W. | (410) 402-6885 | sfeldman@mprc.umaryland.edu |
| Contact: Stephen J Heishman, Ph.D. | (410) 550-1547 | heishman@nih.gov |
| United States, Maryland | |
| University of Maryland at Baltimore/MPRC | Recruiting |
| Catonsville, Maryland, United States, 21228 | |
| Contact: For more information contact Mathew's Media Group Recruiting 800-535-8254 researchstudies@mail.nih.gov | |
| Principal Investigator: | Stephen J Heishman, Ph.D. | National Institute on Drug Abuse (NIDA) |
More Information
| ClinicalTrials.gov Identifier: | NCT01031433 History of Changes |
| Other Study ID Numbers: | 999909449, 09-DA-N449 |
| Study First Received: | December 11, 2009 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
|
Tobacco Craving Virtual Reality Schizophrenia Smoking |
|
Tobacco Use Disorder Schizophrenia Substance-Related Disorders 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 |