Phase 2
N=18
Pharmacogenetics of Naltrexone for Stimulant Abuse
Substance Use Disorders · Methamphetamine Abuse
Bottom Line
View on ClinicalTrials.gov: NCT03226223 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Methamphetamine Self-Administration — 8890; 7116 Clicks on a computer mouse
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intranasal Methamphetamine (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methamphetamine Self-Administration |
8890; 7116 | — |
| SECONDARY Positive Subjective Effects of Methamphetamine. |
53.6; 57.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03226223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.