Nicotine DependenceNCT01031433
Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: The prevalence of cigarette smoking among individuals with schizophrenia is noticeably higher than in the general population, and smoking cessation attempts frequently are unsuccessful in this population. Little is known about the effects of cigarette/nicotine craving in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2009to 18 Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 year old males and females
- Currently smokes at least 5 cigarettes per day
- Current DSM-IV diagnosis of schizophrenia and stable medication regimen
- Medically healthy as determined by screening criteria
- Urine cotinine level greater than or equal to 100 ng/ml (NicAlert reading greater than or equal to 3)
- Agrees to wear a head mounted display (HMD) for up to 45 minutes
- Participant able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80 percent on ESC.
Who cannot join
- Interest in reducing or quitting tobacco use within the past 3 months
- Treatment for tobacco dependence in the past 3 months
- Use of nicotine replacement products, bupropion, or varenicline in the past 3 months as an aid to quit or reduce smoking.
- DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or dependence within the past 6 months
- Current use of serotonin reuptake inhibitors or any medication that would interfere with the protocol in the opinion of MAI
- History of head injury, seizures, or stroke
- Pregnant, nursing, or planning to become pregnant during the study
- Positive urine toxicology screen for substances other than those used for therapeutic purposes: participants who have an initial positive urine toxicology screen for substances other than those used for therapeutic purposes will have the opportunity to return within two weeks for a second toxicology screen. If at that time the results are again positive, the participants will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, 21228
About this study
Background:
- The prevalence of cigarette smoking among individuals with schizophrenia is noticeably higher than in the general population, and smoking cessation attempts frequently are unsuccessful in this population. Little is known about the effects of cigarette/nicotine craving in individuals with schizophrenia. Researchers are interested in learning more about how craving affects people with schizophrenia and developing new ways to treat cravings and improve the effectiveness of smoking cessation therapies and treatments.
- In recent years, virtual reality (VR) has been studied to determine whether it can be used to induce craving by using life-like cue settings. VR cues involving cigarette use, including images of cigarettes and scent cues of tobacco smoke, may be used to elicit craving in smokers. Researchers are interested in learning more about how individuals with schizophrenia respond to specific VR cues and settings.
Read more
Objectives:
- To determine the feasibility of using a contextual real-world paradigm using virtual reality involving cigarette smoking in people with schizophrenia.
- To examine if virtual reality cues will elicit craving in smokers with schizophrenia.
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:
- The study will involve three sessions, with an initial screening visit, a test session, and a follow-up session.
- Screening visit: Participants will be screened with a medical and psychiatric history, and will answer questions about smoking history, current smoking habits and craving patterns, and general anxiety levels. This session will also introduce participants to the operation and use of the VR equipment. Participants who are comfortable using the VR system will return within 2 days for the test session.
- Test session: Participants will use the VR equipment to view neutral scenes and scenes that are designed to elicit cravings for cigarettes. After viewing each scene, participants will answer questions about their overall mood, anxiety levels, and any cigarette cravings they may have.
- Follow-up session: Participants will return 1 week after the VR session to answer questions about mood, anxiety levels, and current smoking habits and craving patterns.
Read the detailed description
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
- Conditions
- Nicotine Dependence
- Keywords
- Tobacco Craving, Virtual Reality, Schizophrenia, Smoking
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS) will be administered to measure cigarette craving during the virtual reality session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start28 Jul 2009
- Study completion18 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen J Heishman, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031433
- Sponsor's protocol ID
- 999909449
- Other IDs
- 09-DA-N449
- Status last verified
- 18 Jul 2012
- First submitted
- 11 Dec 2009
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
PubMed 7165477Bordnick PS, Graap KM, Copp H, Brooks J, Ferrer M, Logue B. Utilizing virtual reality to standardize nicotine craving research: a pilot study. Addict Behav. 2004 Dec;29(9):1889-94. doi: 10.1016/j.addbeh.2004.06.008.
PubMed 15530734Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.
PubMed 10605857
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality
- ClinicalTrials.gov ID
- NCT01031433
- Acronym / sponsor ID
- 999909449
- Conditions
- Nicotine Dependence
- Keywords
- Tobacco Craving, Virtual Reality, Schizophrenia, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 28 Jul 2009
- Study completion
- 18 Jul 2012
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- The prevalence of cigarette smoking among individuals with schizophrenia is noticeably higher than in the general population, and smoking cessation attempts frequently are unsuccessful in this population. Little is known about the effects of cigarette/nicotine craving in individuals with schizophrenia. Researchers are interested in learning more about how craving affects people with schizophrenia and developing new ways to treat cravings and improve the effectiveness of smoking cessation therapies and treatments.
- In recent years, virtual reality (VR) has been studied to determine whether it can be used to induce craving by using life-like cue settings. VR cues involving cigarette use, including images of cigarettes and scent cues of tobacco smoke, may be used to elicit craving in smokers. Researchers are interested in learning more about how individuals with schizophrenia respond to specific VR cues and settings.
Objectives:
- To determine the feasibility of using a contextual real-world paradigm using virtual reality involving cigarette smoking in people with schizophrenia.
- To examine if virtual reality cues will elicit craving in smokers with schizophrenia.
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:
- The study will involve three sessions, with an initial screening visit, a test session, and a follow-up session.
- Screening visit: Participants will be screened with a medical and psychiatric history, and will answer questions about smoking history, current smoking habits and craving patterns, and general anxiety levels. This session will also introduce participants to the operation and use of the VR equipment. Participants who are comfortable using the VR system will return within 2 days for the test session.
- Test session: Participants will use the VR equipment to view neutral scenes and scenes that are designed to elicit cravings for cigarettes. After viewing each scene, participants will answer questions about their overall mood, anxiety levels, and any cigarette cravings they may have.
- Follow-up session: Participants will return 1 week after the VR session to answer questions about mood, anxiety levels, and current smoking habits and craving patterns.
Detailed description
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
Key exclusion criteria (8 listed)
- Interest in reducing or quitting tobacco use within the past 3 months
- Treatment for tobacco dependence in the past 3 months
- Use of nicotine replacement products, bupropion, or varenicline in the past 3 months as an aid to quit or reduce smoking.
- DSM-IV diagnosis of active alcohol or substance abuse in the past 1 month or dependence within the past 6 months
- Current use of serotonin reuptake inhibitors or any medication that would interfere with the protocol in the opinion of MAI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS) will be administered to measure cigarette craving during the virtual reality session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 7165477Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.
- Background: PubMed 15530734Bordnick PS, Graap KM, Copp H, Brooks J, Ferrer M, Logue B. Utilizing virtual reality to standardize nicotine craving research: a pilot study. Addict Behav. 2004 Dec;29(9):1889-94. doi: 10.1016/j.addbeh.2004.06.008.
- Background: PubMed 10605857Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Heishman, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS) will be administered to measure cigarette craving during the virtual reality session.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.