TERMINATED

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

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Conditions

Smoking Cessationschizophrenia spectrum disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-16
Study Completion:2024-12-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06374290

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * fluent in English;
  2. * Diagnosed with schizophrenia spectrum disorder that is currently stable;
  3. * Report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath CO≥10 ppm.
  4. * Meet subjective and objective (urinary drug screen) measures of non-opioid use.
  5. * 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.
  6. * Able to give written informed consent
  7. * Obtain an Evaluation to Sign Consent (ESC) score above 10.
  8. * Have suicidal or homicidal ideation requiring immediate attention.
  9. * Previous use of bupropion or naltrexone in the past 30 days.
  10. * Currently enrolled in treatment for tobacco use.
  11. * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5 )criteria for alcohol and other substance use disorders excluding nicotine and marijuana.
  12. * Report a history of epilepsy, seizure disorder or condition increasing risk of seizure, or head trauma with neurological sequelae.
  13. * Have a current eating disorder.
  14. * Be medically unstable or taking medications that are contraindicated with using naltrexone or bupropion.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-16
Study Completion Date2024-12-04

Study Record Updates

Study Start Date2024-07-16
Study Completion Date2024-12-04

Terms related to this study

Keywords Provided by Researchers

  • schizophrenia spectrum disorder

Additional Relevant MeSH Terms

  • Smoking Cessation