Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Exclusion Criteria19

• Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
• Has suicidal or homicidal ideation that requires immediate attention;
• Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician;
• Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study;
• Has Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening);
• Has any elevated bilirubin test value per laboratory criteria OR any other liver function test (LFT) value > 5 times the upper limit of normal per laboratory criteria;
• Has a platelet count <100 x 10exp3/microliter;
• Has a body habitus that precludes gluteal intramuscular injection of XR-NTX in accordance with the administration equipment (needle) and procedures;
• Has a known allergy or sensitivity to bupropion, naloxone, naltrexone, PLG (polyactideco-glycolide), carboxymethylcellulose or any other component of the XR-NTX diluents;
• Has been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
• Has taken an investigational drug in another study within 30 days of study consent;
• Has been prescribed and taken naltrexone or bupropion within 30 days of study consent;
• Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder (SUD) treatment services;
• Is receiving ongoing treatment with tricyclic antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications;
• Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician;
• Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period;
• Has a surgery planned or scheduled during the study period;
• Is currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities;
• If assigned as female at birth and/or currently has a uterus, is currently pregnant, breastfeeding, or planning on conception.