Clinical trial NCT06374290: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
Official title: Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: schizophrenia spectrum disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Feasibility as assessed by the percentage of participants that enroll in the study
timeFrame: end of treatment (week 3)
measure: Percentage of participants that complete 3 weeks of treatment
timeFrame: end of treatment (week 3)
measure: Safety as assessed by the percentage of participants that show no serious adverse events
timeFrame: end of treatment (week 3)
Secondary outcomes:
measure: Change in number of cigarettes smoked per day (CPD)
timeFrame: Baseline, end of treatment (week 3)
measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)
timeFrame: Baseline, end of treatment (week 3)
measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT)
timeFrame: Baseline, end of treatment (week 3)
measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, end of treatment (week 3)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jin H Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: