Pharmacogenetics of Naltrexone for Stimulant Abuse

NCT03226223 | Completed Phase 2 Results FDA Drug

• 1 other identifier: #7347
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorders; Methamphetamine Abuse

Outcome Measures

Primary Outcomes (1)

• Methamphetamine Self-Administration

  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).

  1 day.

Secondary Outcomes (1)

• Positive Subjective Effects of Methamphetamine.

  1 day

Study Arms (2)

Naltrexone 0 mg

PLACEBO COMPARATOR

This aim assess the effects of pretreatment with 0 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).

Drug: Intranasal Methamphetamine

Naltrexone 50 mg

EXPERIMENTAL

This aim assess the effects of pretreatment with 50 mg of naltrexone on laboratory measures of the abuse potential of methamphetamine (30mg/70 kg).

Drug: Intranasal Methamphetamine

Interventions

Intranasal Methamphetamine DRUG

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

Naltrexone 0 mg; Naltrexone 50 mg

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jermaine Jones
• Organization: New York State Psychiatric Institute

jermaine.jones@nyspi.columbia.edu

6467746113

Study Officials

• Jermaine Jones, PhD

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and study staff conducting the lab sessions will be blinded to the treatment condition (i.e., naltrexone 0 mg or 50 mg)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurobiology (in Psychiatry)

Model Details: Participants will complete two testing sessions in which the effects of oral naltrexone (0 mg \& 50 mg) will be tested in combination with intranasal methamphetamine. Participants will complete two testing sessions (naltrexone 0 mg + Methamphetamine \& naltrexone 50 mg + methamphetamine), in randomized order.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: September 15, 2016
• Primary Completion: July 15, 2019
• Study Completion: July 30, 2020
• Last Updated: November 24, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)