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

NCT ID: NCT06374290

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2024-12-04

Brief 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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Naltrexone (Vivitrol)

Intervention Type: DRUG

At week 1 the Nurse Practitioner will administer extended-release naltrexone via intramuscular gluteal injection supplied as a standard single-use kit containing 380-mg vial of Vivitrol microspheres. Only one naltrexone injection will be administered over the course of the study

Bupropion

Intervention Type: DRUG

Oral bupropion will be titrated to 450 mg over the course of 3 days. One week's supply of the study medication will be dispensed at each visit. Cell-phone assisted remote observation of medication adherence (CAROMA) will be used to assess compliance. Following Week 3, participants will be provided with enough pills to titrate the dose of bupropion over a period of 4 days. Therefore, participants will receive bupropion pills 3 weeks plus 4 additional days to titrate down the dose.

Interventions

Naltrexone (Vivitrol)

At week 1 the Nurse Practitioner will administer extended-release naltrexone via intramuscular gluteal injection supplied as a standard single-use kit containing 380-mg vial of Vivitrol microspheres. Only one naltrexone injection will be administered over the course of the study

Intervention Type: DRUG

Bupropion

Oral bupropion will be titrated to 450 mg over the course of 3 days. One week's supply of the study medication will be dispensed at each visit. Cell-phone assisted remote observation of medication adherence (CAROMA) will be used to assess compliance. Following Week 3, participants will be provided with enough pills to titrate the dose of bupropion over a period of 4 days. Therefore, participants will receive bupropion pills 3 weeks plus 4 additional days to titrate down the dose.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jin Ho Yoon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin H Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-24-0024

Identifier Type: -

Identifier Source: org_study_id