Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
NCT ID: NCT06233799
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-07-01
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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XR-NTX/BUP-XL
Participants randomized to the (XR-NTX/BUP-XL) arm will receive 450 mg of once-daily oral extended-release bupropion tablets and once every three weeks (Weeks 1, 4, 7, and 10) injections of extended-release naltrexone (Vivitrol®)
extended-release naltrexone (XR-NTX)
Once per three weeks injections of extended-release naltrexone
extended release bupropion (BUP-XL) tablets (BUP-XL)
Daily oral extended release bupropion tablets
PLB/PLB
Participants randomized to the PLB arm will receive once-daily placebo tablets and once every three weeks (Weeks 1, 4, 7, and 10) placebo injections.
iPLB
Once per three weeks injections of placebo
oPLB
Daily oral placebo tablets
Interventions
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extended-release naltrexone (XR-NTX)
Once per three weeks injections of extended-release naltrexone
extended release bupropion (BUP-XL) tablets (BUP-XL)
Daily oral extended release bupropion tablets
iPLB
Once per three weeks injections of placebo
oPLB
Daily oral placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Raul Mandler, MD
Role: PRINCIPAL_INVESTIGATOR
NIDA/NIH
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California Los Angeles
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
CODA
Portland, Oregon, United States
MUSC/BHS
Pickens, South Carolina, United States
University of Tennessee
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Alison Oliveto, PhD
Role: primary
Jesse Clark, MD
Role: primary
Leslie Hulvershorn, MD
Role: primary
Olawale Ojo, MD
Role: backup
Gavin Bart, MDPhD
Role: primary
Tara Chowdhury, PhD
Role: primary
Susan Sonne, PharmD
Role: primary
Ronald Cowan, MDPhD
Role: primary
Manish Jha, MD
Role: primary
Nassima Ait-Daoud Tiouririne, MD
Role: primary
Other Identifiers
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NIDA/VA CS #1036
Identifier Type: -
Identifier Source: org_study_id
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