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Drug-Drug Interaction Between THC and AEF0117

NCT06395688 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-02-27

No results posted yet for this study

Summary

This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence.

The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.

Conditions

  • Cannabis Abuse

Interventions

DRUG

3ß-(4-methoxybenzyloxy)pregn-5-en-20-one

AEF0117 soft capsules of 1mg

DRUG

Placebo

Placebo soft capsules (identical to active compound)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Aelis Farma

    lead INDUSTRY

Principal Investigators

  • Margaret Haney, PhD · New York Institute Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

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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 NCT06395688 on ClinicalTrials.gov