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New drug combo aimed at helping smokers with schizophrenia

NCT ID NCT06374290

Disease control Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early pilot study tested whether a combination of injectable naltrexone and oral bupropion could help people with schizophrenia who smoke cigarettes. Only 2 participants were enrolled before the study was terminated. The main goals were to see if the treatment was feasible and safe, and to measure changes in smoking habits and schizophrenia symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naltrexone (injectable) and bupropion (oral)
What this could lead to
If it works, this could point toward a new treatment option to help people with schizophrenia quit smoking.
What could go wrong
This was a very small pilot study (only 2 participants) that was terminated early, so results are limited. It is too early to know if the combination is effective or safe for this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

2 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

schizophrenia Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoking cessation

Contacts and locations

Locations

  • The University of Texas health Science Center at Houston

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.