NCT03190161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

May 25, 2017

Last Update Submit

August 13, 2019

Conditions

SchizophreniaNicotine DependenceSmoking, Tobacco

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

Schizophrenia Patients

EXPERIMENTAL

Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder

Behavioral: Music session

Interventions

Music sessionBEHAVIORAL

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.

Schizophrenia Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

SchizophreniaTobacco Use DisorderTobacco Smoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced DisordersSmokingBehaviorTobacco Use

Study Officials

  • Kathleen Tracy, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 16, 2017

Study Start

March 9, 2017

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

US(1)