Search / Trial NCT06233799

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

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Jan 22, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a combination treatment using naltrexone and bupropion for individuals struggling with methamphetamine use disorder (MUD). The goal is to find out if this treatment can help people reduce or stop their use of methamphetamine more effectively than a placebo (a treatment with no active medication). The trial is currently recruiting participants who are between the ages of 18 and 65, and who have been diagnosed with moderate to severe MUD. To qualify, individuals should have used methamphetamine on multiple occasions in the month before signing up and must be interested in reducing or quitting their drug use.

Participants in this study can expect to receive either the active medication or a placebo, and they will be monitored closely throughout the trial. They will also need to use a smartphone app to record their medication intake daily. It's important to note that there are specific health criteria that need to be met for eligibility, such as not being physically dependent on opioids and not having certain medical or psychiatric conditions. This trial aims to provide valuable information that could lead to better treatments for those facing challenges with methamphetamine use.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. Is 18 to 65 years of age;
  • • 2. Meets DSM-5 criteria for moderate or severe MUD (4 or more criteria);
  • • 3. Is interested in reducing or stopping MA use;
  • • 4. Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
  • • 5. Self-reports MA use on 18 or more days in the 30-day period prior to consent using the Timeline Followback (TLFB);
  • • 6. Provides at least 2 urine samples positive for MA out of up to 3 tests, which will occur at least 2 days apart within a 10-day period;
  • • 7. If assigned as female at birth and/or currently has a uterus, is not pregnant, agrees to use acceptable birth control methods, and have periodic urine pregnancy testing done during participation in the study unless documentation of hysterectomy provided;
  • • 8. Is not physically dependent on opioids and meets subjective and objective measures of being opioid-free prior to naltrexone injection per study medical clinician's determination, including, if clinically required, a negative naloxone challenge;
  • • 9. Is willing to comply with all study procedures and medication instructions;
  • • 10. Agrees to use a smartphone app (downloaded for free to own device or on a study provided smartphone device) to take daily videos of medication dosing.
  • Exclusion Criteria:
  • • 1. Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
  • • 2. Has suicidal or homicidal ideation that requires immediate attention;
  • • 3. 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;
  • • 4. 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;
  • • 5. 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);
  • • 6. 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;
  • • 7. Has a platelet count \<100 x 10exp3/microliter;
  • • 8. Has a body habitus that precludes gluteal intramuscular injection of XR-NTX in accordance with the administration equipment (needle) and procedures;
  • • 9. Has a known allergy or sensitivity to bupropion, naloxone, naltrexone, PLG (polyactideco-glycolide), carboxymethylcellulose or any other component of the XR-NTX diluents;
  • • 10. Has been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
  • • 11. Has taken an investigational drug in another study within 30 days of study consent;
  • • 12. Has been prescribed and taken naltrexone or bupropion within 30 days of study consent;
  • • 13. Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder (SUD) treatment services;
  • • 14. 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;
  • • 15. 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;
  • • 16. Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period;
  • • 17. Has a surgery planned or scheduled during the study period;
  • • 18. 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;
  • • 19. If assigned as female at birth and/or currently has a uterus, is currently pregnant, breastfeeding, or planning on conception.

Trial Officials

Shwe Gyaw, MD

Principal Investigator

NIDA/NIH

About National Institute On Drug Abuse (Nida)

The National Institute on Drug Abuse (NIDA) is a leading federal agency within the U.S. Department of Health and Human Services, dedicated to advancing the understanding of drug abuse and addiction through rigorous scientific research. NIDA's mission encompasses the exploration of the biological, behavioral, and social aspects of substance use disorders, facilitating the development of effective prevention and treatment strategies. By funding and conducting innovative clinical trials, NIDA aims to translate research findings into practical solutions that improve public health and inform policy, ultimately contributing to the reduction of substance-related harm in communities across the nation.

Locations

Little Rock, Arkansas, United States

Minneapolis, Minnesota, United States

Indianapolis, Indiana, United States

Charlottesville, Virginia, United States

Portland, Oregon, United States

San Diego, California, United States

Dallas, Texas, United States

Pickens, South Carolina, United States

Memphis, Tennessee, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0