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Music 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
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 25, 2017
Last Updated
August 13, 2019
Sponsor
NYU Langone Health
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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

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Music to Reduce Use of Smoking in Patients With Schizophrenia

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