NCT03226223

Pharmacogenetics of Naltrexone for Stimulant Abuse

Completed Phase 2 Results posted Last updated 24 November 2020

What this trial tests

Phase 2 trial testing Intranasal Methamphetamine in Substance Use Disorders in 18 participants. Completed in 30 July 2020.

Timeline

15 September 2016

Primary endpoint
15 July 2019

30 July 2020

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	18
Start date	15 September 2016
Primary completion	15 July 2019
Estimated completion	30 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Intranasal Methamphetamine — full drug profile →

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →
• Methamphetamine Abuse — all drugs for Methamphetamine Abuse →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 21 to 50, any sex, with Substance Use Disorders or Methamphetamine Abuse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Methamphetamine Self-Administration Primary · 1 day.

To assess the reinforcing effects of methamphetamine, participants complete a drug self-administration procedure. The outcome measure for this procedure is the number of operant responses (clicks on a mouse) participant are willing to make in order to receive drug (methamphetamine).

Group	Value	95% CI
Naltrexone 0 mg	8890	± 3509
Naltrexone 50 mg	7116	± 3080

Positive Subjective Effects of Methamphetamine. Secondary · 1 day

Participant ratings of methamphetamine "Liking," on a 100 mm visual analog scale. Participants are asked to indicate on a 100 mm line the extent to which they agree with the description of the drug provided. The 0 mm end of the line indicates "Not at All," while the 100 mm indicates "Extremely."

Group	Value	95% CI
Naltrexone 0 mg	53.6	± 38.9
Naltrexone 50 mg	57.2	± 32.5

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effects of acute oral naltrexone pretreatment on the abuse potential of intranasal methamphetamine, and the relationship between reward/punishment sensitivity and methamphetamine's effects.
   Jones JD, Mumtaz M, Vadhan NP, Martinez S, et al · · 2022 · cited 4× · PMID 35438671 · DOI 10.1097/fbp.0000000000000671
2. Role of Nanomedicine in Transforming Pharmacotherapy for Substance Use Disorder (SUD).
   Patne AY, Mohapatra S, Mohapatra SS. · · 2025 · cited 2× · PMID 40190158 · DOI 10.1002/wnan.70008