Pharmacogenetics of Naltrexone for Stimulant Abuse

Completed · Phase 2

Conditions studied: Substance Use Disorders, Methamphetamine Abuse

In brief

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.

Key facts

Study ID

NCT03226223

Run by

New York State Psychiatric Institute

People needed

18

Starts

2016-09-15

Expected to finish

2020-07-30

Last updated by the study team

2020-11-24

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age 21 to 50 years
• DSM-5 criteria for mild-to-severe stimulant use disorder, along with intravenous, intranasal or smoked use of amphetamine-type stimulants in amounts equal to or greater than administered in the current study.
• Able to give written informed consent to participate.
• Females must be either post-menopausal, surgically sterilized, or using an acceptable method of contraception (double-barrier method like a condom with a spermicidal lubricant) to participate in this study.
• Racially Caucasian or of European descent.

You may not qualify if…

• Currently seeking treatment for a substance use disorder.
• DSM-5 criteria for moderate-to-severe substance use disorders (except those involving cocaine, amphetamines and nicotine).
• Psychiatric condition that may affect the participants' ability to provide informed consent (e.g., psychotic disorder), or make participation hazardous for the participant or study staff (e.g., severe depression/suicidality, or risk of violence).
• Uncontrolled neurological, cardiovascular, and hepatic diseases, active tuberculosis, or any other disorder that might make administration of study medications hazardous.
• Gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medication or medical treatment.
• Current treatment with a psychotropic medication that in the physician's judgement would interfere with the study endpoints.
• History of allergy, adverse reaction, or sensitivity to amphetamines.
• Medical conditions that may make study participation hazardous:
• History of seizures or cardiac risk conditions (unstable angina, cardiac arrhythmias, chest pain, strong palpitations (subjectively defined as the feeling that the heart is beating too hard, too fast, skipping a beat, or fluttering).
• Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal).
• Impaired renal function (creatinine > 1.2).
• Hypertension (>140/90).
• Asthmatic symptoms within the past 3 years.

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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