Music to Reduce Use of Smoking in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Music to Reduce Use of Smoking in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190161
• Other study ID #: 17-00001
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: September 17, 2018

Study information

• Verified date: August 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Schizophrenia
• Smoking, Tobacco
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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