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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of two medications, injectable naltrexone and oral bupropion, to help people with schizophrenia who want to quit smoking cigarettes. The goal is to see if this combination of medications is safe and effective for individuals diagnosed with schizophrenia spectrum disorders who smoke regularly. Participants will be monitored for changes in their smoking habits and any effects on their symptoms related to schizophrenia.

To be eligible for the study, participants need to be between the ages of 65 and 74, speak fluent English, and have a stable diagnosis of schizophrenia. They should be smoking at least five cigarettes a day and have a breath test indicating recent smoking. Women in the study must not be pregnant or breastfeeding and agree to use birth control. During the trial, participants will receive the medications and be regularly checked for their health and progress. It's important to know that those with certain mental health issues or medical conditions may not be able to participate for their safety.

Gender

ALL

Eligibility 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.