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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment
  • 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
  • Drug: 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.

Recruiting Locations

The University of Texas health Science Center at Houston
Houston, Texas 77030
Contact:
Jin H Yoon, PhD
713-486-2800
jin.ho.yoon@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jin H Yoon, PhD
713-486-2800
jin.ho.yoon@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.