NCT06374290

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

Name: Clinical Trial NCT06374290
Creator: The University of Texas Health Science Center, Houston
Keywords: Smoking Cessation, Naltrexone (Vivitrol), Phase 1, drug, clinical trial, United States of America

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

The University of Texas Health Science Center, Houston·Phase 1·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Smoking Cessation
Drug/Device/Intervention: Naltrexone (Vivitrol)
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: The University of Texas Health Science Center, Houston
Location: Houston, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: May 01, 2024
End date: Apr 15, 2025
Enrollment: 20 participants

Primary outcome

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

Summary

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.

ICD-10 classifications

Mental and behavioural disorders due to use of tobacco withdrawal stateTobacco useExposure to tobacco smokeToxic effect: Tobacco and nicotineMental and behavioural disorders due to use of tobacco

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06374290
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06374290 through Pure Global AI's free database. This Phase 1 trial is sponsored by The University of Texas Health Science Center, Houston and is currently Recruiting. The study focuses on Smoking Cessation. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.