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View Clinical Trial (Medical Research Study)
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Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality - NCT01031433-21228 (Clinical Trial 447235)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy447235.aspx
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| City: |
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Catonsville |
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State:
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MD |
| Zip Code: |
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21228 |
| Conditions: |
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Nicotine Dependence |
| Purpose: |
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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 recruit 16 smokers with a DSM IV diagnosis of schizophrenia.
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.
Outcome Measures:
During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS) 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 has 6-items which include: I
am thinking about how I can get cigarettes ; I am thinking about the next time I will use
cigarettes , I want to buy cigarettes ; I have the urge or desire to use cigarettes , and
if I was offered a cigarette I could resist . 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
Tobacco Craving Questionnaire (TCQ-SF), the Brief Questionnaire of Smoking Urges
(QSU-Brief), 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.
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| Study summary: |
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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 recruit 16 smokers with a DSM IV diagnosis of schizophrenia.
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 |
| Criteria: |
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- INCLUSION CRITERIA:
1. 18-45 year old males and females
2. Currently smokes at least 5 cigarettes per day
3. Current DSM-IV diagnosis of schizophrenia and stable medication regimen
4. Medically healthy as determined by screening criteria
5. Urine cotinine level greater than or equal to 100 ng/ml (NicAlert(Registered
Trademark) reading greater than or equal to 3)
6. Agrees to wear a head mounted display (HMD) for up to 30 minutes
EXCLUSION CRITERIA:
1. Interest in reducing or quitting tobacco use within the past 3 months
2. Treatment for tobacco dependence in the past 3 months
3. Use of nicotine replacement products, bupropion, or varenicline in the past 3 months
4. DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or
dependence within the past 6 months
5. Current use of serotonin reuptake inhibitors or any medication that would interfere
with the protocol in the opinion of MAI
6. History of head injury, seizures, or stroke
7. Pregnant, nursing, or planning to become pregnant during the study
8. Positive urine toxicology screen |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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