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

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.

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.