Cited by 281Substance Abuse Treatment and OutcomesOpioid Use Disorder TreatmentNeurotransmitter Receptor Influence on Behavior

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Bupropion and Naltrexone in Methamphetamine Use Disorder

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Trivedi, Madhukar H., Walker, Robrina, Ling, Walter, dela Cruz, Adriane, Sharma, Gaurav, Carmody, Thomas, Ghitza, Udi E., Wahle, Aimee, Kim, Mora, Shores-Wilson, Kathy, Sparenborg, Steven, Coffin, Phillip, Schmitz, Joy, Wiest, Katharina, Bart, Gavin, Sonne, Susan C., Wakhlu, Sidarth, Rush, A. John, Nunes, Edward V., Shoptaw, Steven·2021·New England Journal of Medicine

DOI 10.1056/nejmoa2020214PMC PMC8111570

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Abstract

BACKGROUND: The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied. METHODS: We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses. RESULTS: A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial. CONCLUSIONS: Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).

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Authors: Trivedi, M. H., Walker, R., Ling, W., dela Cruz, A., Sharma, G., Carmody, T., Ghitza, U. E., Wahle, A., Kim, M., Shores-Wilson, K., Sparenborg, S., Coffin, P., Schmitz, J., Wiest, K., Bart, G., Sonne, S. C., Wakhlu, S., Rush, A. J., Nunes, E. V., & Shoptaw, S.
Affiliations: Texas Tech University (US)
From the Peter O’Donnell Jr. Brain Institute at the University of Texas Southwestern Medical Center (M.H.T.) and the University of Texas Southwestern Medical Center (R.W., A.C., T.C., M.K., K.S.-W., S.W.), Dallas, the University of Texas Health Science Center at Houston, Houston (J.S.), and Texas Tech University, Permian Basin, Odessa (A.J.R.); the University of California, Los Angeles, Los Angeles (W.L., S. Shoptaw); the Emmes Company, Rockville (G.S., A.W.), and the National Institute on Drug...
ORCID: Trivedi, Madhukar H.
Walker, Robrina
Ling, Walter
Sharma, Gaurav
Carmody, Thomas
Ghitza, Udi E.
Coffin, Phillip
Schmitz, Joy
Wiest, Katharina
Bart, Gavin
Rush, A. John
Nunes, Edward V.
Shoptaw, Steven
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2021-01-14
Volume: 384
Issue: 2
Pages: 140-153
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2020214
PMC: PMC8111570
OpenAlex: W3118735640
Cited by: 281
References: 30
Citations by year: 2026: 49 · 2025: 45 · 2024: 45 · 2023: 63 · 2022: 43 · 2021: 35
FWCI: 33.49
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: U.S. Department of Health and Human Services (Contract No. HHSN271201500065C; HHSN271201400028C)
National Institute on Drug Abuse (UG1DA020024; UG1DA013035; UG1DA040316; UG1DA013727)
Topics: Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Keywords: methamphetamine dependence, naltrexone, bupropion, combination pharmacotherapy, treatment response, adverse events, drug addiction treatment, urine drug testing, relapse prevention, opioid antagonists, antidepressants, stimulant use disorder, treatment efficacy and safety, serious adverse events
MeSH terms: Administration, Oral, Adolescent, Adult, Aged, Delayed-Action Preparations, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Injections, Male, Methamphetamine, Middle Aged, Naltrexone, Narcotic Antagonists, Bupropion, Amphetamine-Related Disorders, Medication Adherence, Young Adult

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