Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality

NCT01031433 | Completed

• 2 other identifiers: 99990944909-DA-N449
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Dependence

Keywords

Tobacco Craving; Virtual Reality; Schizophrenia; Smoking

Outcome Measures

Primary Outcomes (1)

• During the Cue trials the Cigarette Craving Visual Analogue Scale (CCVAS) will be administered to measure cigarette craving during the virtual reality session.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Maryland at Baltimore/MPRC

Catonsville, Maryland, 21228, United States

Location

Related Publications (3)

• Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.

  PMID: 7165477 BACKGROUND

• Bordnick 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.

  PMID: 15530734 BACKGROUND

• Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.

  PMID: 10605857 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Schizophrenia; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavior

Study Officials

• Stephen J Heishman, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: July 28, 2009
• Study Completion: July 18, 2012
• Last Updated: December 12, 2019

Record last verified: 2012-07-18

Locations

US (1)