Back to resultsMusic to Reduce Use of Smoking in Patients With Schizophrenia
Primary Purpose
Schizophrenia, Nicotine Dependence, Smoking, Tobacco
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music session
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
- smoked at least 10 cigarettes per day for the past month
- score of 4 or more on the Fagerstrom Test for Nicotine Dependence73
- psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)
- the capacity to participate in the informed consent process
Exclusion Criteria:
- being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)
- report active substance abuse or testing positive drug or alcohol use
- taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment
- participating in any treatment or activity that includes music as a focus
- having a seizure disorder, other neurological illnesses, or a family history of seizures
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Schizophrenia Patients
Arm Description
Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
Outcomes
Primary Outcome Measures
Snaith-Hamilton Pleasure Scale (SHAPS)
Measures Pleasure Pre Music Session
Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session
Measures Pleasure Post Music Session
Pleasure Rating Scale (PRS)
Measures Pleasure Pre Music Session
Pleasure Rating Scale (PRS) Post Music Session
Measures Pleasure Post Music Session
Questionnaire of Smoking Urges-Brief (QSU-B)
Measures Cravings Pre Music Session
Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session
Measures Cravings Post Music Session
Minnesota Nicotine Withdrawal Scale (MNWS)
Measures Withdrawal Pre Music Session and Post Music Session
Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session
Measures Withdrawal Post Music Session
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190161
Brief Title
Music to Reduce Use of Smoking in Patients With Schizophrenia
Official Title
Music to Reduce Use of Smoking in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Nicotine Dependence, Smoking, Tobacco
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia Patients
Arm Type
Experimental
Arm Description
Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
Intervention Type
Behavioral
Intervention Name(s)
Music session
Intervention Description
Participants will be asked to refrain from smoking from 24 hours before the music listening session as confirmed by breath carbon monoxide level <6 ppm on the day of the session. They will be contacted by phone or in person at the clinic as a reminder prior.
Primary Outcome Measure Information:
Title
Snaith-Hamilton Pleasure Scale (SHAPS)
Description
Measures Pleasure Pre Music Session
Time Frame
1 Day
Title
Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session
Description
Measures Pleasure Post Music Session
Time Frame
1 Day
Title
Pleasure Rating Scale (PRS)
Description
Measures Pleasure Pre Music Session
Time Frame
1 Day
Title
Pleasure Rating Scale (PRS) Post Music Session
Description
Measures Pleasure Post Music Session
Time Frame
1 Day
Title
Questionnaire of Smoking Urges-Brief (QSU-B)
Description
Measures Cravings Pre Music Session
Time Frame
1 Day
Title
Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session
Description
Measures Cravings Post Music Session
Time Frame
1 Day
Title
Minnesota Nicotine Withdrawal Scale (MNWS)
Description
Measures Withdrawal Pre Music Session and Post Music Session
Time Frame
1 Day
Title
Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session
Description
Measures Withdrawal Post Music Session
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder
smoked at least 10 cigarettes per day for the past month
score of 4 or more on the Fagerstrom Test for Nicotine Dependence73
psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)
the capacity to participate in the informed consent process
Exclusion Criteria:
being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)
report active substance abuse or testing positive drug or alcohol use
taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment
participating in any treatment or activity that includes music as a focus
having a seizure disorder, other neurological illnesses, or a family history of seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Tracy, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Music to Reduce Use of Smoking in Patients With Schizophrenia
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