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Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review.

Authors :
Kiluk BD
Kleykamp BA
Comer SD
Griffiths RR
Huhn AS
Johnson MW
Kampman KM
Pravetoni M
Preston KL
Vandrey R
Bergeria CL
Bogenschutz MP
Brown RT
Dunn KE
Dworkin RH
Finan PH
Hendricks PS
Houtsmuller EJ
Kosten TR
Lee DC
Levin FR
McRae-Clark A
Raison CL
Rasmussen K
Turk DC
Weiss RD
Strain EC
Source :
JAMA psychiatry [JAMA Psychiatry] 2023 Jan 01; Vol. 80 (1), pp. 84-92.
Publication Year :
2023

Abstract

Importance: Novel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous μ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In November 2019, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration sponsored a meeting to discuss the current evidence regarding potential treatments for OUD, including cannabinoids, psychedelics, sedative-hypnotics, and immunotherapeutics, such as vaccines.<br />Observations: Consensus recommendations are presented regarding the most critical elements of trial design for the evaluation of novel OUD treatments, such as: (1) stage of treatment that will be targeted (eg, seeking treatment, early abstinence/detoxification, long-term recovery); (2) role of treatment (adjunctive with or independent of existing OUD treatments); (3) primary outcomes informed by patient preferences that assess opioid use (including changes in patterns of use), treatment retention, and/or global functioning and quality of life; and (4) adverse events, including the potential for opioid-related relapse or overdose, especially if the patient is not simultaneously taking maintenance MOR agonist or antagonist medications.<br />Conclusions and Relevance: Applying the recommendations provided here as well as considering input from people with lived experience in the design phase will accelerate the development, translation, and uptake of effective and safe therapeutics for individuals struggling with OUD.

Details

Language :
English
ISSN :
2168-6238
Volume :
80
Issue :
1
Database :
MEDLINE
Journal :
JAMA psychiatry
Publication Type :
Academic Journal
Accession number :
36449315
Full Text :
https://doi.org/10.1001/jamapsychiatry.2022.4020