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Treatment for Smoking Cessation

Phase 1

Waitlist Available

Led By Jin H Yoon, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with schizophrenia spectrum disorder that is currently stable

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment (week 3)

Awards & highlights

Study Summary

This trial aims to test if giving a combination of injectable naltrexone and oral bupropion to individuals with schizophrenia who smoke cigarettes is safe and possible. They will also look at how

Who is the study for?

This trial is for adults with schizophrenia who smoke cigarettes and are interested in quitting. Participants should be stable on their antipsychotic medication, not currently pregnant or breastfeeding, and without a history of seizures or opioid use.Check my eligibility

What is being tested?

The study tests the combination of injectable Naltrexone (380 mg) and oral Bupropion (450 mg daily) to see if it helps people with schizophrenia quit smoking. It will also look at how this combo affects their schizophrenia symptoms.See study design

What are the potential side effects?

Possible side effects include nausea, headaches, insomnia, dry mouth from Bupropion; Naltrexone may cause injection site reactions, nausea/vomiting, headache, dizziness. Both drugs could potentially worsen psychiatric symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My schizophrenia is currently under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (week 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment (week 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (week 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility as assessed by the percentage of participants that enroll in the study

Percentage of participants that complete 3 weeks of treatment

Safety as assessed by the percentage of participants that show no serious adverse events

Secondary outcome measures

Change in number of cigarettes smoked per day (CPD)

Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)

Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupropion

2011

Completed Phase 4

~3310

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

906 Previous Clinical Trials

323,094 Total Patients Enrolled

Jin H Yoon, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

2 Previous Clinical Trials

64 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of risk does this therapy pose to individuals undergoing treatment?

"Given that this trial is classified as a Phase 1 study, there exists limited evidence supporting both the safety and efficacy of the treatment. As such, our team at Power rates its safety level as 1 on a scale from 1 to 3."

Answered by AI

Are patients currently eligible to enroll in this research study?

"The trial listed on clinicaltrials.gov is presently not open for enrollment. Despite being initially posted and last updated on April 15, 2024, it is currently inactive regarding participant recruitment. However, there are a noteworthy 488 other ongoing trials actively seeking candidates as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

Jin Ho Yoon 2024. "Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06374290.

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