Music to Reduce Use of Smoking in Patients With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Nicotine Dependence; Smoking, Tobacco
• Intervention / Treatment: Behavioral: Music session

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Schizophrenia Patients; Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder	Behavioral: Music session; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Snaith-Hamilton Pleasure Scale (SHAPS)	Measures Pleasure Pre Music Session	1 Day
Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session	Measures Pleasure Post Music Session	1 Day
Pleasure Rating Scale (PRS)	Measures Pleasure Pre Music Session	1 Day
Pleasure Rating Scale (PRS) Post Music Session	Measures Pleasure Post Music Session	1 Day
Questionnaire of Smoking Urges-Brief (QSU-B)	Measures Cravings Pre Music Session	1 Day
Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session	Measures Cravings Post Music Session	1 Day
Minnesota Nicotine Withdrawal Scale (MNWS)	Measures Withdrawal Pre Music Session and Post Music Session	1 Day
Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session	Measures Withdrawal Post Music Session	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Kathleen Tracy, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): September 17, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Tobacco Use Disorder
• Other Study ID Numbers: 17-00001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No