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Trial record 25 of 3314 for:    schizophrenia

Music to Reduce Use of Smoking in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190161
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Nicotine Dependence Smoking, Tobacco Behavioral: Music session Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Music to Reduce Use of Smoking in Patients With Schizophrenia
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 1 Day ]
    Measures Pleasure Pre Music Session

  2. Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session [ Time Frame: 1 Day ]
    Measures Pleasure Post Music Session

  3. Pleasure Rating Scale (PRS) [ Time Frame: 1 Day ]
    Measures Pleasure Pre Music Session

  4. Pleasure Rating Scale (PRS) Post Music Session [ Time Frame: 1 Day ]
    Measures Pleasure Post Music Session

  5. Questionnaire of Smoking Urges-Brief (QSU-B) [ Time Frame: 1 Day ]
    Measures Cravings Pre Music Session

  6. Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session [ Time Frame: 1 Day ]
    Measures Cravings Post Music Session

  7. Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: 1 Day ]
    Measures Withdrawal Pre Music Session and Post Music Session

  8. Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session [ Time Frame: 1 Day ]
    Measures Withdrawal Post Music Session



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190161


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Kathleen Tracy, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03190161     History of Changes
Other Study ID Numbers: 17-00001
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Schizophrenia
Additional relevant MeSH terms:
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Tobacco Use Disorder
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders