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Pharmacogenetics of Naltrexone for Stimulant Abuse

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ClinicalTrials.gov Identifier: NCT03226223
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jermaine Jones, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Methamphetamine Abuse Drug: Intranasal Methamphetamine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: Participants and study staff conducting the lab sessions will be blinded to the treatment condition (i.e., naltrexone 0 mg or 50 mg)
Primary Purpose: Basic Science
Official Title: Using Pharmacogenetics to Better Evaluate Naltrexone for Treating Stimulant Abuse
Actual Study Start Date : September 15, 2016
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Placebo Comparator: Naltrexone 0 mg
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
Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)

Experimental: Naltrexone 50 mg
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
Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)




Primary Outcome Measures :
  1. Percentage of methamphetamine choices. [ Time Frame: 1 day. ]
    To assess the reinforcing effects of methamphetamine, participants complete a drug vs. money self-administration procedure. The outcome measure for this procedure is their percentage of choices for drug (methamphetamine) choices.


Secondary Outcome Measures :
  1. Positive subjective effects of methamphetamine. [ Time Frame: 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."



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age 21 to 50 years
  2. 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.
  3. Able to give written informed consent to participate.
  4. 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.
  5. Racially Caucasian or of European descent.

Exclusion Criteria:

  1. Currently seeking treatment for a substance use disorder.
  2. DSM-5 criteria for moderate-to-severe substance use disorders (except those involving cocaine, amphetamines and nicotine).
  3. 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).
  4. Uncontrolled neurological, cardiovascular, and hepatic diseases, active tuberculosis, or any other disorder that might make administration of study medications hazardous.
  5. Gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medication or medical treatment.
  6. Current treatment with a psychotropic medication that in the physician's judgement would interfere with the study endpoints.
  7. History of allergy, adverse reaction, or sensitivity to amphetamines.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226223


Contacts
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Contact: Jermaine Jones, PhD 646 774-6113 jermaine.jones@nyspi.columbia.eu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jermaine Jones, PhD    646-774-6113    jermaine.jones@nyspi.columbia.edu   
Principal Investigator: Jermaine Jones, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Jermaine Jones, PhD NYSPI

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Responsible Party: Jermaine Jones, Assistant Professor of Clinical Neurobiology (in Psychiatry), New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03226223     History of Changes
Other Study ID Numbers: #7347
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Methamphetamine
Central Nervous System Stimulants
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors