SchizophreniaNCT03190161
Music to Reduce Use of Smoking in Patients With Schizophrenia
A study testing Music session in people with Schizophrenia and Nicotine Dependence, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Nicotine Dependence, Smoking, Tobacco
- What is being tested?
- Music session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 17 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Schizophrenia, Nicotine Dependence, Smoking, Tobacco
- Being tested
- Music session
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia, Tobacco Use Disorder, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia Patients | Experimental | Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder Receives: Behavioral: Music session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snaith-Hamilton Pleasure Scale (SHAPS)
Measures Pleasure Pre Music Session
Measured: 1 Day
Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session
Measures Pleasure Post Music Session
Measured: 1 Day
Pleasure Rating Scale (PRS)
Measures Pleasure Pre Music Session
Measured: 1 Day
Pleasure Rating Scale (PRS) Post Music Session
Measures Pleasure Post Music Session
Measured: 1 Day
Questionnaire of Smoking Urges-Brief (QSU-B)
Measures Cravings Pre Music Session
Measured: 1 Day
Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session
Measures Cravings Post Music Session
Measured: 1 Day
Minnesota Nicotine Withdrawal Scale (MNWS)
Measures Withdrawal Pre Music Session and Post Music Session
Measured: 1 Day
Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session
Measures Withdrawal Post Music Session
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start9 Mar 2017
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Tracy, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190161
- Sponsor's protocol ID
- 17-00001
- Status last verified
- Aug 2019
- First submitted
- 25 May 2017
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music to Reduce Use of Smoking in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03190161
- Acronym / sponsor ID
- 17-00001
- Conditions
- Schizophrenia, Nicotine Dependence, Smoking, Tobacco
- Keywords
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia Patients | Experimental | Behavioral: Music sessionClinician verification diagnosis of Schizophrenia or Schizoaffective Disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music sessionParticipants 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. | Behavioural | Schizophrenia Patients |
Primary outcome
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: 1 Day
Measures Pleasure Pre Music Session
Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session
Time frame: 1 Day
Measures Pleasure Post Music Session
Pleasure Rating Scale (PRS)
Time frame: 1 Day
Measures Pleasure Pre Music Session
Pleasure Rating Scale (PRS) Post Music Session
Time frame: 1 Day
Measures Pleasure Post Music Session
Questionnaire of Smoking Urges-Brief (QSU-B)
Time frame: 1 Day
Measures Cravings Pre Music Session
Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session
Time frame: 1 Day
Measures Cravings Post Music Session
Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: 1 Day
Measures Withdrawal Pre Music Session and Post Music Session
Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session
Time frame: 1 Day
Measures Withdrawal Post Music Session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Tracy, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music session in people with Schizophrenia and Nicotine Dependence, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snaith-Hamilton Pleasure Scale (SHAPS) (time frame: 1 Day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.