Study of Pomaglumetad and Methamphetamine

NCT03106571 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: R01DA043238
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.

Conditions

Methamphetamine Use Disorder

Keywords

Phase 1 clinical trial

Outcome Measures

Primary Outcomes (4)

• Blood pressure

  Blood pressure following IV methamphetamine during treatment with pomaglumetad or placebo

  0 to 240 minutes after IV methamphetamine

• Heart rate

  Heart rate following IV methamphetamine during treatment with pomaglumetad or placebo

  0 to 240 minutes after IV methamphetamine

• Rate-pressure product

  Rate-pressure product (heart rate \* systolic blood pressure, a measure of myocardial oxygen consumption and workload) following IV methamphetamine during treatment with pomaglumetad or placebo

  0 to 240 minutes after IV methamphetamine

• Methamphetamine subjective effects

  Self-reported methamphetamine subjective effects assessed with Drug Effect Questionnaire (DEQ-5) and Methamphetamine-based Questionnaire for Stimulant Urges (MA-QSU) following IV methamphetamine during treatment with pomaglumetad or placebo

  0 to 240 minutes after IV methamphetamine

Secondary Outcomes (1)

• Peak methamphetamine concentration

  0 to 48 hours after IV methamphetamine

Other Outcomes (1)

• Mean choices for methamphetamine

  on day of methamphetamine infusion

Study Arms (4)

Pomaglumetad methionil Low + Methamphetamine

EXPERIMENTAL

Pomaglumetad 40 mg orally twice daily x 9 days with intravenous methamphetamine challenges

Drug: Pomaglumetad methionil; Drug: Methamphetamine

Pomaglumetad methionil Mid + Methamphetamine

EXPERIMENTAL

Pomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 80 mg orally twice daily x 8 days with intravenous methamphetamine challenges

Drug: Pomaglumetad methionil; Drug: Methamphetamine

Pomaglumetad methionil High + Methamphetamine

EXPERIMENTAL

Pomaglumetad 40 mg orally twice daily x 1 day then pomaglumetad 160 mg orally twice daily x 8 days with intravenous methamphetamine challenges

Drug: Pomaglumetad methionil; Drug: Methamphetamine

Control + Methamphetamine

PLACEBO COMPARATOR

1-4 placebo tabs orally twice daily x 9 days (to match pomaglumetad dosing in each cohort) with intravenous methamphetamine challenges

Drug: Placebo; Drug: Methamphetamine

Interventions

Pomaglumetad methionil DRUG

Tablets twice daily

Pomaglumetad methionil High + Methamphetamine; Pomaglumetad methionil Low + Methamphetamine; Pomaglumetad methionil Mid + Methamphetamine

Placebo DRUG

1-4 tablets twice daily

Control + Methamphetamine

Methamphetamine DRUG

intravenous methamphetamine

Control + Methamphetamine; Pomaglumetad methionil High + Methamphetamine; Pomaglumetad methionil Low + Methamphetamine; Pomaglumetad methionil Mid + Methamphetamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• not seeking treatment for MA problems at the time of the study;
• English-speaking;
• age 18-55 years inclusive;
• meet DSM-5 criteria for MA use disorder, moderate-severe as diagnosed via MINI;
• have a self-reported history of using MA either via injection or smoking and provide at least one MA-positive urine prior to admission;
• provide a urine drug screen negative for all illicit drugs, excepting THC, on the day of scheduled inpatient admission;
• report methamphetamine use on 10 or more days in the past 30 days at baseline;
• have a resting heart rate ≤ 100 bpm, systolic blood pressure ≤ 160 mm Hg, and diastolic blood pressure ≤ 100 mm Hg prior to admission;
• have a baseline EKG that demonstrates normal sinus rhythm, QTc ≤ 450 msec in men or QTc ≤ 460 msec in women, and no clinically significant arrhythmias;
• if female (except females of non-childbearing potential-e.g., at least 1 year post-menopausal or surgically sterile), not pregnant confirmed by negative pregnancy test nor lactating and willing to use a medically approved method of birth control to prevent pregnancy during the trial and for 40 days after the last dose of study medication;
• if male, willing to refrain from donating sperm during the study and for 100 days following the last dose of study medication and agree that they and their partners will use a medically approved contraceptive method;
• have a medical history and physical/neurological examination demonstrating no additional clinically significant contraindications for study participation, in the judgment of the investigators;
• able to participate in all scheduled evaluations, likely to complete all scheduled tests, and likely to be adherent, in the opinion of the investigator and;
• agree not to post any personal medical data or information related to the study on any social media site or website until the trial has completed.

You may not qualify if:

• non-English speaking;
• currently on probation or parole;
• have current cocaine, opioid, marijuana, or alcohol use disorder, moderate-severe;
• have liver function tests (total bilirubin, ALT, AST, or alkaline phosphatase) ≥ 2 x the upper limit of normal or kidney function tests (creatinine and BUN) ≥ 2 x the upper limit of normal;
• current or past history of seizure disorder;
• a history of head trauma that resulted in neurological sequelae;
• major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar illness but excepting stable major depressive disorder, generalized anxiety disorder, etc.) as assessed by the MINI;
• have a current neurological disorder (e.g., organic brain disease, dementia) or medical condition which would make study compliance difficult or compromise informed consent;
• current ongoing treatment with psychotropic medications (e.g. antidepressants, antipsychotics, antiepileptics, sedative/hypnotics, narcotic analgesics);
• history of suicide attempt(s) in the past 6 months or active suicidal intention or plan (score 4 or 5) in the past month as assessed by the C-SSRS;
• evidence of clinically significant heart disease or hypertension;
• evidence of untreated or unstable serious medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease including active tuberculosis infection;
• have HIV infection and currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication;
• have a medical condition that makes maintaining reliable intravenous access impossible;
• donated blood or plasma within 3 months of inpatient admission;

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA

Santa Monica, California, 90404, United States

Location

MeSH Terms

Interventions

pomaglumetad methionil; Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Keith Heinzerling, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 10, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)