At a glance
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The ION+EMI Study: Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM
In Brief
A Phase 2 clinical trial evaluating Naltrexone Hydrochloride, Placebo, and 1 other intervention for Methamphetamine Use Disorder. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This is a double-blind, placebo-controlled phase 2b trial in which 54 MSM who use meth will be randomly assigned (2:1) to receive 12 weeks of as-needed intermittent oral naltrexone 50 mg enhanced with an EMA-informed EMI platform, or receive as-needed placebo with EMA-informed EMI. The 12-week treatment period is consistent with other pharmacotherapy trials for substance use disorders. The proposed sample size is also consistent with other phase 2b trials for substance use treatment. Upon enrollment, participants will complete daily EMA assessments and weekly visits for behavioral surveys and urine testing for meth metabolites, study drug dispensing and computer-based counseling for substance use. Safety laboratory assessments and vital signs will be completed monthly. Efficacy (Specific Aims 1-3) will be assessed upon trial completion as measured by proportion meth-positive urine samples; PrEP and ART adherence by drug levels and viral load testing; and sexual risk behavior data accounting for PrEP use and viral suppression.
Study Details
Timeline
Interventions
Intermittent Oral Naltrexone, 50 mg
Intermittent Oral Placebo
Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for "high risk" meth use.