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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190161
Other study ID # 17-00001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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