Pharmacogenetics of Naltrexone for Stimulant Abuse

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03226223
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Completed
Phase	Phase 2
Start date	September 15, 2016
Completion date	July 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05660434` - Using Aromatherapy in Substance Use Disorder	N/A
Active, not recruiting	`NCT05338268` - Substance Use and Loneliness	N/A
Completed	`NCT03954184` - E-health Implementation (Iowa)	N/A
Completed	`NCT04098614` - Barriers to Substance Use Disorder Recovery	N/A
Completed	`NCT03590106` - Cardiac Surgery Peer Recovery Support Program	N/A
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Recruiting	`NCT06273228` - Parenting Young Children in Pediatrics	N/A
Recruiting	`NCT05327504` - Written Exposure Therapy for Veterans With SUD and PTSD	N/A
Terminated	`NCT03517111` - The Impact of a Parenting Intervention on Latino Youth Health Behaviors	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT04401215` - Technologically-Augmented Referrals to Mitigate Addiction Consequences	N/A
Not yet recruiting	`NCT06163651` - Evaluating a One-Year Version of the Parent-Child Assistance Program	N/A
Not yet recruiting	`NCT06187701` - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients	N/A
Recruiting	`NCT04296604` - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations	N/A
Active, not recruiting	`NCT02382042` - Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans	N/A
Completed	`NCT01237366` - Study Targeting Affect Regulation	Phase 1/Phase 2
Terminated	`NCT01356667` - Drum-Assisted Therapy for Native Americans	N/A
Completed	`NCT00708890` - Twelve Step Based Self-help Groups for Substance Related Disorders	N/A
Active, not recruiting	`NCT04048850` - Zepatier in Patients With Substance Use
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2