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Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction

NCT03813095 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-07-27

No results posted yet for this study

Summary

The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.

Conditions

  • Addiction
  • Opioid Dependence
  • Opioid Withdrawal

Interventions

DRUG

APH-1501

The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.

DRUG

Placebo

The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.

Sponsors & Collaborators

  • Aphios

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-09-30
Completion
2025-12-31
FDA Drug
Yes

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Drugs
Diseases

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 NCT03813095 on ClinicalTrials.gov