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

Description

The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.

Conditions

Smoking Cessation

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Study Overview

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Study Details

Study overview

The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.

Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

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

Condition
Smoking Cessation
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Jin H Yoon, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2025-04-15