NCT04850664

Brief Summary

Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly brain stimulation system that increased 6-month treatment retention of OUDs in a pilot study; and also, acutely reduced opioid withdrawal severity and negative affect during induction into opioid maintenance therapy. This study will establish its effectiveness in a broad category of OUD subjects at different stages of OUD care continuum.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

March 26, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

March 8, 2021

Last Update Submit

July 30, 2021

Conditions

Opioid Use Disorder, ModerateOpioid Use Disorder, SevereWithdrawal SymptomsCravingNegative Affectivity

Keywords

Opioid Use DisordersBuprenorphine Maintenance TreatmentOrbitofrontal cortex (OFC)CBOTRelapse Prevention

Outcome Measures

Primary Outcomes (24)

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    2 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    4 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    6 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    8 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    10 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    12 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    14 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    16 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    18 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    20 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    22 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    24 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    26 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    28 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    30 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    32 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    34 weeks after baseline

  • 6-month buprenorphine maintenance treatment (BMT) retention

    6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

    36 weeks after baseline

  • Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week

    The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.

    Screening to Week 12 Treatment

  • Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24

    The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.

    Screening to Week 24

  • Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month

    he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.

    Screening visit to Week 12

  • Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month

    he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.

    Screening visit to Week 24

  • Change from Screening in negative affect severity in the PANAS

    The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.

    Screening visit to Week 12

  • Change from Screening in negative affect severity in the PANAS

    The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.

    Screening visit to Week 24

Secondary Outcomes (7)

  • Opioid Relapse

    Screening visit to Week 12

  • Pre-Intervention changes in SOWS from Screening at Week 2

    Screening visit to Week 2

  • Post-Intervention changes in SOWS from Week 12 at Week 13

    Week 12 to Week 13

  • Pre-Intervention changes in OCS from Screening to Week 2

    Screening visit to Week 2

  • Post-Intervention changes in OCS from Week 12 to Week 13

    Week 12 to Week 13

  • +2 more secondary outcomes

Study Arms (2)

CBOT + TAU

EXPERIMENTAL

CBOT consists of 40 cycles of olfactory stimulation and OFC training tasks, lasting \~45 minutes, once daily over 3 months. Treatment-as-usual (TAU) is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).

Drug: CBOT + TAU

Sham + TAU

SHAM COMPARATOR

Sham is a CBOT device that uses artificially-scented compressed room air instead of olfactory stimulants and has no OFC cognitive tasks. Similar to the CBOT, sham will be used daily for 45 minutes. TAU is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).

Drug: Sham + TAU

Interventions

CBOT + TAUDRUG

The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time. It is paired with OFC-dependent cognitive tasks.

Also known as: plant based essential oils
CBOT + TAU
Sham + TAUDRUG

Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.

Sham + TAU

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18- 70years
  • Diagnosis of current moderate or severe OUD in the past 6 months, including the past one month
  • Willing to receive study interventions and buprenorphine during the study
  • Do not meet criteria for current moderate or severe use of other substance use disorders (except nicotine use disorder)
  • Diagnosis of Major Depressive Disorder, Anxiety disorders, and Post-traumatic Stress disorders will be included as long as the symptoms are stable, no suicidal ideas or plans and there are no recent changes in treatment of these conditions in the last 6 weeks prior to enrollment
  • No intranasal disease
  • Willing to participate by signing the informed consent form and
  • Have a place to stay when receiving the intervention.

You may not qualify if:

  • Any significant neurologic disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy or seizures
  • Mental retardation
  • Schizophrenia or bipolar disorders
  • Experiencing current suicide ideas or plans
  • Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, and liver cirrhosis, as determined by site PI
  • History of severe traumatic nose injury that affects ability to smell, as determined by site PI
  • Allergies or intolerance to aromas from plant essential oils (e.g. orange and lemon)
  • Breastfeeding or Pregnancy test positive.
  • On parole or probation mandated to receive treatment for OUD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinics of Dr. Edwin Chapman @ MHDG

Washington D.C., District of Columbia, 20002, United States

RECRUITING

Family and Medical Counseling Service, Inc

Washington D.C., District of Columbia, 20020, United States

RECRUITING

Howard University

Washington D.C., District of Columbia, 20060, United States

RECRUITING

Maryland Treatment Centers @ Avery Road Treatment Center

Rockville, Maryland, 20853, United States

RECRUITING

Related Publications (5)

  • Jackson C, Rai N, McLean CK, Hipolito MMS, Hamilton FT, Kapetanovic S, Nwulia EA. Overlapping Risky Decision-Making and Olfactory Processing Ability in HIV-Infected Individuals. Clin Exp Psychol. 2017 Sep;3(3):160. doi: 10.4172/2471-2701.1000160. Epub 2017 Aug 15.

    PMID: 29057388BACKGROUND

  • Volkow ND, Fowler JS. Addiction, a disease of compulsion and drive: involvement of the orbitofrontal cortex. Cereb Cortex. 2000 Mar;10(3):318-25. doi: 10.1093/cercor/10.3.318.

    PMID: 10731226BACKGROUND

  • Lucantonio F, Takahashi YK, Hoffman AF, Chang CY, Bali-Chaudhary S, Shaham Y, Lupica CR, Schoenbaum G. Orbitofrontal activation restores insight lost after cocaine use. Nat Neurosci. 2014 Aug;17(8):1092-9. doi: 10.1038/nn.3763. Epub 2014 Jul 20.

    PMID: 25042581BACKGROUND

  • Temple DM. Isolation techniques for pharmacologically active substances (animal). Annu Rev Pharmacol. 1969;9:407-18. doi: 10.1146/annurev.pa.09.040169.002203. No abstract available.

    PMID: 4894805BACKGROUND

  • Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.

    PMID: 19235739BACKGROUND

MeSH Terms

Conditions

Opioid-Related DisordersLymphoma, FollicularSubstance Withdrawal Syndrome

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Evaristus A Nwulia, MD

    Evon Medics LLC

    PRINCIPAL INVESTIGATOR

  • Tanya Alim, MD

    Howard University

    PRINCIPAL INVESTIGATOR

  • Mark Johnson, MD

    Howard University

    PRINCIPAL INVESTIGATOR

  • Marc Fishman, MD

    Maryland Treatment Centers

    PRINCIPAL INVESTIGATOR

  • Michael Serlin, MD

    Family and Medical Counseling Service, Inc

    PRINCIPAL INVESTIGATOR

  • Edwin Chapman, MD

    Clinics of Dr. Edwin C. Chapman, MD, PC @ MHDG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evaristus A Nwulia, MD, MHS

CONTACT

410-227-2005enwulia@evonmedics.org

Maria M Hipolito, MD

CONTACT

571-241-2766mhipolito@evonmedics.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Evon Medics will perform randomization of participants stratified by sex at site level. Site staff and participants will be blinded to treatment assignment.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Scientific Officer

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 20, 2021

Study Start

March 26, 2021

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)