Evidence map›Paper›PMID 27379819›Full record

ArticleJournal of addiction medicine

Utilizing a Two-stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-daily Bupropion as a Treatment for Methamphetamine Use Disorder.

Larissa J Mooney, Maureen P Hillhouse, Christie Thomas, Alfonso Ang, Gaurav Sharma, Garth Terry, Linda Chang, Robrina Walker, Madhukar Trivedi, David Croteau and 2 more

Open access · greenAbstract read
In one paragraph

Article in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Guideline
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  5. Bupropion and Naltrexone in Methamphetamine Use Disorder.The New England journal of medicine · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Larissa J MooneyUniversity of California (LJM, MPH, CT, AA, GT, WL), Los Angeles, Los Angeles, CA; Emmes (GS, DC), Rockville, MD; University of Hawaii and the Queen's Medical Center (LC), Honolulu, HI; University of Texas Southwestern Medical Center (RW, MT), Dallas, TX; and National Institute on Drug Abuse (SS), Bethesda, MD.
Maureen P Hillhouse
Christie Thomas
Alfonso Ang
Gaurav Sharma
Garth Terry
Linda Chang
Robrina Walker
Madhukar Trivedi
David Croteau
Steven Sparenborg
Walter Ling
Emmes (United States) · USFundación Juan March · ESUniversity of Hawaii System · USUniversity of California, Los Angeles · USThe University of Texas Southwestern Medical Center · US

Funding

Project-004UG1DA020024 · NIDA · UT SOUTHWESTERN MEDICAL CENTER · PI Steven J Shoptaw, MADHUKAR H. TRIVEDI · 2015 to 2026
$71.6M
The National Drug Abuse Treatment Clinical Trials NetworkU10DA013045 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LING, WALTER NMN · 1999 to 2015
$52.6M
NIDA NIH HHS U10 DA013045NIDA NIH HHS UG1 DA020024
6 · The paper itself

Abstract

objectivesThis 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder.

methodsThe study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform. Participants met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for severe MA use disorder, self-reported ≥20 days of MA use in the 30 days prior to consent, and submitted 3 MA-positive urine drug screens (UDS) out of 4 collected during screening. Participants attended clinic twice weekly for observed BRP dosing, UDS testing, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9.

resultsAnalyses evaluated effects of XR-NTX + BRP to determine the number of "responders" according to a statistically predefined response criterion (6 of 8 MA-negative UDS during the last 4 weeks of medication). The 2-stage design required that stage 1 yield ≥3 responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2).

conclusionsUnder the statistical analysis plan, study "success" required ≥9 responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study.

Indexed as

Outcome Assessment, Health CareAdultAgedAmphetamine-Related DisordersBupropionDelayed-Action PreparationsDopamine Uptake InhibitorsDrug Therapy, CombinationFemaleHumansMaleMethamphetamineMiddle AgedNaltrexoneNarcotic AntagonistsPilot ProjectsBupropionDelayed-Action PreparationsDopamine Uptake InhibitorsMethamphetamineNaltrexoneNarcotic Antagonists

Identifiers

PMID27379819
PMCPMC4969133
OpenAlexW2460385725

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.