Injectable naltrexone and oral bupropion for smokers with schizophrenia
Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
This study is testing if a combination of an injectable medication and a pill can help people with schizophrenia who smoke cigarettes quit smoking and improve their mental health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06374290 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of using injectable naltrexone in combination with oral bupropion for individuals diagnosed with schizophrenia spectrum disorders who smoke cigarettes. Participants will receive a dose of 380 mg of naltrexone and 450 mg of bupropion daily, with the aim of assessing changes in smoking behavior and schizophrenia symptoms. The study focuses on individuals who are stable in their mental health condition and meet specific smoking criteria. The primary goal is to determine the effectiveness of this combined treatment approach in promoting smoking cessation.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with a stable schizophrenia spectrum disorder who smoke at least five cigarettes per day.
Not a fit: Patients with active substance use disorders or those currently undergoing treatment for tobacco use may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly aid individuals with schizophrenia in quitting smoking, improving their overall health and quality of life.
How similar studies have performed: While this approach is novel, similar studies have shown promise in using pharmacotherapy for smoking cessation among individuals with mental health disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * fluent in English; * Diagnosed with schizophrenia spectrum disorder that is currently stable; * Report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath CO≥10 ppm. * Meet subjective and objective (urinary drug screen) measures of non-opioid use. * If female, present a negative pregnancy test, not be currently breast feeding, and agree to use acceptable birth control methods and receive periodic pregnancy tests during the course of the study. * Able to give written informed consent * Obtain an Evaluation to Sign Consent (ESC) score above 10. Exclusion Criteria. * Have suicidal or homicidal ideation requiring immediate attention. * Previous use of bupropion or naltrexone in the past 30 days. * Currently enrolled in treatment for tobacco use. * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5 )criteria for alcohol and other substance use disorders excluding nicotine and marijuana. * Report a history of epilepsy, seizure disorder or condition increasing risk of seizure, or head trauma with neurological sequelae. * Have a current eating disorder. * Be medically unstable or taking medications that are contraindicated with using naltrexone or bupropion.
Where this trial is running
Houston, Texas
- The University of Texas health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jin H Yoon, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Jin H Yoon, PhD
- Email: jin.ho.yoon@uth.tmc.edu
- Phone: 713-486-2800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.