Digital-Chemosensory Training for Substance Use Disorders

This study is testing a new approach called EDITOR (Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders) for people with substance use disorders, including opioid, alcohol, cocaine, and methamphetamine use disorders. EDITOR uses a device that stimulates your sense of smell and your brain (orbitofrontal cortex) to help with recovery. We are comparing EDITOR to a similar device (CBOT) and usual care to see if EDITOR helps people stay in treatment longer. You may be able to join if you are 18-80 years old and have a moderate or severe substance use disorder. The study aims to enroll 300 adults.

Study design
This interventional study plans to enroll 300 adult participants. It compares EDITOR to CBOT and usual care to see which is more effective.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants stay in treatment at 14 days, 28 days, and 8 weeks after starting.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06434818

Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders

UNKNOWN
PHASE2Ages 18–80InterventionalTreatment
Evon Medics LLC
~300 participants
Updated 2024-05-30 on ClinicalTrials.gov
What's tested:EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)CBOT with olfactory stimulants & OFC tasksCBOT Sham

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention in SUD treatment
Measured over Baseline to day 14
+9 more outcomes measured
Substance Use Disorders
Opioid Use Disorder
Alcohol Use Disorder
Cocaine Use Disorder
Methamphetamine-dependence
3 sites across 2 states
District of Columbia2
Maryland1
  • Charles Nwaokobia · PRINCIPAL_INVESTIGATOR · Evon Medics LLC
  • Evaristus Nwulia, MD · PRINCIPAL_INVESTIGATOR · Evon Medics LLC
  • Tanya Alim, MD · PRINCIPAL_INVESTIGATOR · Howard University
  • Edwin Chapman, MD · PRINCIPAL_INVESTIGATOR · Clinics of Dr. Edwin Chapman at MHDG
  • Marc Fishman, MD · PRINCIPAL_INVESTIGATOR · Maryland Treatment Centers, Inc.

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  • Retention in SUD treatmentBaseline to day 14

    3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  • Retention in SUD treatmentBaseline to day 28

    3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  • Retention in SUD treatmentBaseline to 8 weeks

    3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  • Retention in SUD treatmentBaseline to three months

    3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  • SUD Relapse RateBaseline to day 7

    Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  • SUD Relapse RateBaseline to day 14

    Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  • SUD Relapse RateBaseline to day 28

    Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  • SUD Relapse RateBaseline to 8 weeks

    Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  • SUD Relapse RateBaseline to three months

    Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  • SUD engagementBaseline to day 14

    SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.