RELEVANCE: Despite numerous clinical trials, no medication has been approved to treat methamphetamine (MA) dependence. As a result, novel approaches to medication development for MA dependence, including linked medication development, where work in early safety trials can be used to inform the importance of continued (or not) assessment of novel or combination pharmacotherapies, is needed.
DESCRIPTION: Following up on the Phase I safety trial, the objective of this study is to test the safety and potential efficacy of ibudilast to treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce methamphetamine use and increase treatment retention more than placebo among patients seeking treatment for methamphetamine dependence. As HIV infection is a common complication of methamphetamine dependence, half of the participants will be HIV positive and the study will assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4 count, risk behaviors).
OUTCOMES: Results of this study can be found in the following publication:
1.Heinzerling KG, Briones M, Thames AD, Hinkin CH, Zhu T, Wu YN, Shoptaw SJ. Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder. J Neuroimmune Pharmacol. 2020 Jun;15(2):238-248. Epub 2019 Dec 9. PMID: 31820289; PMCID: PMC8651052.