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Study for Naltrexone on the Abuse Potential of Methylphenidate

NCT03769064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-12-07

No results posted yet for this study

Summary

The current abuse liability study aims to assess the potential for co-administration of naltrexone (NTX) to reduce the abuse potential of methylphenidate (MPH).

Conditions

  • Naltrexone
  • Methylphenidate Abuse

Interventions

DRUG

Placebo

Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).

DRUG

Methylphenidate 60 mg

Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).

DRUG

Treatment Phase Sequence 4213

Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.

DRUG

Treatment Phase Sequence 2134

Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.

DRUG

Treatment Phase Sequence 1342

Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.

DRUG

Treatment Phase Sequence 3421

Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.

Sponsors & Collaborators

  • Avekshan LLC

    lead INDUSTRY

Principal Investigators

  • Pradeep Bhide, PhD · Co-Founder and Chief Scientist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2018-06-20
Completion
2018-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769064 on ClinicalTrials.gov