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

The University of Texas System (UT)

Status and phase

Terminated

Phase 1

Conditions

Smoking Cessation

Treatments

Drug: Naltrexone (Vivitrol)

Drug: Bupropion

Study type

Interventional

Funder types

Other

Identifiers

NCT06374290

HSC-MS-24-0024

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.