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

NCT06374290 | Terminated Phase 1 FDA Drug

• 1 other identifier: HSC-MS-24-0024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

schizophrenia spectrum disorder

Outcome Measures

Primary Outcomes (3)

• Feasibility as assessed by the percentage of participants that enroll in the study

  end of treatment (week 3)

• Percentage of participants that complete 3 weeks of treatment

  end of treatment (week 3)

• Safety as assessed by the percentage of participants that show no serious adverse events

  end of treatment (week 3)

Secondary Outcomes (4)

• Change in number of cigarettes smoked per day (CPD)

  Baseline, end of treatment (week 3)

• Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)

  Baseline, end of treatment (week 3)

• Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT)

  Baseline, end of treatment (week 3)

• Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)

  Baseline, end of treatment (week 3)

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Naltrexone (Vivitrol); Drug: Bupropion

Interventions

Naltrexone (Vivitrol) 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

Treatment

Bupropion 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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Naltrexone; vivitrol; Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Jin H Yoon, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: July 16, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)