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

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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Naltrexone (Vivitrol); Drug: Bupropion

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment

Drug: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	This is a 10 item questionnaire and each is cored from 0(strongly disagree) to 10(strongly agree) for a maximum score of 100, higher score indicating more smoking urge	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)	This will utilize a hypothetical purchasing task, which will assess hypothetical purchase and consumption of cigarettes as a function of increasing cigarette price.	Baseline, end of treatment (week 3)
Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)	This is an 18 item questionnaire and each is scores from 1 (not present) to 7 (extremely severe),with a total score between 18 and 126, higher number indicating worse outcome	Baseline, end of treatment (week 3)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jin H Yoon, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia spectrum disorder
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Ketones; Propiophenones; Naltrexone; Bupropion; vivitrol
• Other Study ID Numbers: HSC-MS-24-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No