Smoking CessationPhase 1NCT06374290
Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
A Phase 1 study testing Naltrexone (Vivitrol) and Bupropion in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Naltrexone (Vivitrol) and Bupropion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 4 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Smoking Cessation
- Being tested
- Naltrexone (Vivitrol), Bupropion
- Keywords
- schizophrenia spectrum disorder
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BupropionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Naltrexone (Vivitrol); Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the percentage of participants that enroll in the study
Measured: end of treatment (week 3)
Percentage of participants that complete 3 weeks of treatment
Measured: end of treatment (week 3)
Safety as assessed by the percentage of participants that show no serious adverse events
Measured: end of treatment (week 3)
Secondary outcomes (4)
Change in number of cigarettes smoked per day (CPD)
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, end of treatment (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start16 Jul 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Why it stopped: Unable to recruit eligible participants and expiration of study medication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ho Yoon, The University of Texas Health Science Center, Houston
- Investigators
- Jin H Yoon, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374290
- Sponsor's protocol ID
- HSC-MS-24-0024
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT06374290
- Acronym / sponsor ID
- HSC-MS-24-0024
- Conditions
- Smoking Cessation
- Keywords
- schizophrenia spectrum disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit eligible participants and expiration of study medication.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Naltrexone (Vivitrol), Drug: Bupropion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treatment |
| BupropionOral 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. | Drug | Treatment |
Primary outcome
Feasibility as assessed by the percentage of participants that enroll in the study
Time frame: end of treatment (week 3)
Percentage of participants that complete 3 weeks of treatment
Time frame: end of treatment (week 3)
Safety as assessed by the percentage of participants that show no serious adverse events
Time frame: end of treatment (week 3)
4 secondary outcomes
Change in number of cigarettes smoked per day (CPD)
Time frame: Baseline, end of treatment (week 3)
Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)
Time frame: 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)
Time frame: Baseline, end of treatment (week 3)
Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, end of treatment (week 3)
Results and safety
The study was stopped early (reason given: Unable to recruit eligible participants and expiration of study medication.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin H Yoon, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone (Vivitrol) and Bupropion in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit eligible participants and expiration of study medication.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the percentage of participants that enroll in the study (time frame: end of treatment (week 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.