NCT03226223

Pharmacogenetics of Naltrexone for Stimulant Abuse

Using Pharmacogenetics to Better Evaluate Naltrexone for Treating Stimulant Abuse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This investigation will be the first study assessing genetic modulation of naltrexone's NTX effects upon the abuse liability of a stimulant drug (methamphetamine). The study team will assess the ability of oral NTX to block the reinforcing and positive subjective effects of intranasal (IN) methamphetamine (30mg/70kg). This investigation could identify an important Gene x Pharmacological interaction, contributing to the personalization of stimulant abuse pharmacotherapy.

Detailed description

A recent meta-analysis concluded that the OPRM1 A118G SNP (rs1799971) significantly moderates the treatment efficacy of Naltrexone (NTX) in treating alcohol abuse, increasing the treatment efficacy by over 2-fold among G-allele carriers (AG/GG). The proposed application would be the first to investigate the moderating effect of this genotype in the efficacy of NTX to treat stimulant abuse. More specifically, the study team proposes to investigate the interaction between NTX and intranasal (IN) methamphetamine (30mg/70kg). Participants who meet DSM criteria for mild-to-severe stimulant use disorder (N=up to 70) will complete 4 testing sessions where drug effects are tested following pretreatment with NTX (0, 50 mg). Naltrexone pretreatment effects upon the abuse liability of IN methamphetamine will be assessed using self-report measurements of positive subjective effects and drug self-administration. Medication effects on these validated predictors of abuse potential will be compared between A118G A allele homozygotes (AA) and G-allele carriers (AG/GG; an anticipated 25% of the total sample), in order to assess genetic moderation of treatment outcome.

Conditions

• Substance Use Disorders
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	Intranasal Methamphetamine	Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)

Timeline

• Start date: 2016-09-15
• Primary completion: 2019-07-15
• Completion: 2020-07-30
• First posted: 2017-07-21
• Last updated: 2020-11-24
• Results posted: 2020-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study