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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374290
• Other study ID #: HSC-MS-24-0024
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Jin H Yoon, PhD
• Phone: 713-486-2800
• Email: jin.ho.yoon[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 symptoms of schizophrenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia
• Smoking Cessation

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	The University of Texas health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the percentage of participants that enroll in the study		end of treatment (week 3)
Primary	Percentage of participants that complete 3 weeks of treatment		end of treatment (week 3)
Primary	Safety as assessed by the percentage of participants that show no serious adverse events		end of treatment (week 3)
Secondary	Change in number of cigarettes smoked per day (CPD)		Baseline, end of treatment (week 3)
Secondary	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)
Secondary	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)
Secondary	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)