NCT06233799 Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
| NCT ID | NCT06233799 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | National Institute on Drug Abuse (NIDA) |
| Condition | Methamphetamine-dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2024-07-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) compared to matched injectable and oral placebo (iPLB/oPLB) in reducing methamphetamine (MA) use in individuals with moderate or severe methamphetamine use disorder (MUD) seeking to stop or reduce MA use.
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.
Contact & Investigator
Raul Mandler, MD
PRINCIPAL INVESTIGATOR
NIDA/NIH
Frequently Asked Questions
Who can join the NCT06233799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Methamphetamine-dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06233799 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT06233799 currently recruiting?
Yes, NCT06233799 is actively recruiting participants. Contact the research team at Jennifer.Wong3@nih.gov for enrollment information.
Where is the NCT06233799 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, San Diego, United States, Indianapolis, United States and 7 additional locations.
Who is sponsoring the NCT06233799 clinical trial?
NCT06233799 is sponsored by National Institute on Drug Abuse (NIDA). The principal investigator is Raul Mandler, MD at NIDA/NIH. The trial plans to enroll 360 participants.