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Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder (CBOT-OUD)

Primary Purpose

Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBOT + TAU
Sham + TAU
Sponsored by
Evon Medics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use Disorder, Moderate focused on measuring Opioid Use Disorders, Buprenorphine Maintenance Treatment, Orbitofrontal cortex (OFC), CBOT, Relapse Prevention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Clinics of Dr. Edwin Chapman @ MHDGRecruiting
  • Family and Medical Counseling Service, IncRecruiting
  • Howard UniversityRecruiting
  • Maryland Treatment Centers @ Avery Road Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CBOT + TAU

Sham + TAU

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Opioid Relapse
Relapse is defined as presence of self-reported repeated (i.e. 2 or more) use after the first two weeks for stabilization of buprenorphine dose, and/or presence of positive urine drug test for opiates. Ascertainment of opioid relapse is through: (a) Survey question administered 2-weekly, inquiring how days in the past did the subject use heroin, prescription opiates and/or other drugs; the dates of drug use; and the quantity (or dose) of drugs used; and (b) Biochemical verification of drug use, through urine samples will be collected and tested every two weeks.
Pre-Intervention changes in SOWS from Screening at Week 2
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).
Post-Intervention changes in SOWS from Week 12 at Week 13
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).
Pre-Intervention changes in OCS from Screening to Week 2
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Post-Intervention changes in OCS from Week 12 to Week 13
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
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). The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.

Full Information

First Posted
March 8, 2021
Last Updated
July 30, 2021
Sponsor
Evon Medics LLC
Collaborators
National Institute on Drug Abuse (NIDA), Howard University, Family and Medical Counseling Service, Inc, Maryland Treatment Centers @ ARTC, Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
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1. Study Identification

Unique Protocol Identification Number
NCT04850664
Brief Title
Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Acronym
CBOT-OUD
Official Title
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evon Medics LLC
Collaborators
National Institute on Drug Abuse (NIDA), Howard University, Family and Medical Counseling Service, Inc, Maryland Treatment Centers @ ARTC, Clinics of Dr. Edwin Chapman, MD, PC @ MHDG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Evon Medics proposes to evaluate the effectiveness of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT), as an alternative strategy for relapse prevention in patients with Opioid Use (OUD) and other substance use disorders (SUD). This treatment leverages the overlap in brain regions that process smell and mediate decision making. The CBOT is portable and can be used at home. This clinical trial is being conducted to demonstrate its utility for home application by nontreatment seeking and treatment-seeking OUD populations, to engage in long-term, successful opioid recovery. Key objectives of this project are to: (1) establish the effectiveness of CBOT for improved retention and relapse prevention in a large sample of OUD subjects; (2) establish its effectiveness for acute reduction of withdrawal severity and negative affect early in recovery; and (3) evaluate its safety, user-friendliness and acceptability. Accomplishment of these goals would lead to larger clinical trials for OUD and wider applications of CBOT in other addictive disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms, Craving, Negative Affectivity
Keywords
Opioid Use Disorders, Buprenorphine Maintenance Treatment, Orbitofrontal cortex (OFC), CBOT, Relapse Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Evon Medics will perform randomization of participants stratified by sex at site level. Site staff and participants will be blinded to treatment assignment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBOT + TAU
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham + TAU
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
CBOT + TAU
Other Intervention Name(s)
plant based essential oils
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sham + TAU
Intervention Description
Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.
Primary Outcome Measure Information:
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
2 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
4 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
6 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
8 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
10 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
12 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
14 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
16 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
18 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
20 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
22 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
24 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
26 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
28 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
30 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
32 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
34 weeks after baseline
Title
6-month buprenorphine maintenance treatment (BMT) retention
Description
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.
Time Frame
36 weeks after baseline
Title
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week
Description
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.
Time Frame
Screening to Week 12 Treatment
Title
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24
Description
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.
Time Frame
Screening to Week 24
Title
Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month
Description
he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.
Time Frame
Screening visit to Week 12
Title
Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month
Description
he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.
Time Frame
Screening visit to Week 24
Title
Change from Screening in negative affect severity in the PANAS
Description
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Time Frame
Screening visit to Week 12
Title
Change from Screening in negative affect severity in the PANAS
Description
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Time Frame
Screening visit to Week 24
Secondary Outcome Measure Information:
Title
Opioid Relapse
Description
Relapse is defined as presence of self-reported repeated (i.e. 2 or more) use after the first two weeks for stabilization of buprenorphine dose, and/or presence of positive urine drug test for opiates. Ascertainment of opioid relapse is through: (a) Survey question administered 2-weekly, inquiring how days in the past did the subject use heroin, prescription opiates and/or other drugs; the dates of drug use; and the quantity (or dose) of drugs used; and (b) Biochemical verification of drug use, through urine samples will be collected and tested every two weeks.
Time Frame
Screening visit to Week 12
Title
Pre-Intervention changes in SOWS from Screening at Week 2
Description
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).
Time Frame
Screening visit to Week 2
Title
Post-Intervention changes in SOWS from Week 12 at Week 13
Description
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).
Time Frame
Week 12 to Week 13
Title
Pre-Intervention changes in OCS from Screening to Week 2
Description
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Time Frame
Screening visit to Week 2
Title
Post-Intervention changes in OCS from Week 12 to Week 13
Description
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Time Frame
Week 12 to Week 13
Title
Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2
Description
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Time Frame
Screening visit to Week 2
Title
Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
Description
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). The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Time Frame
Week 12 to Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evaristus A Nwulia, MD, MHS
Phone
410-227-2005
Email
enwulia@evonmedics.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria M Hipolito, MD
Phone
571-241-2766
Email
mhipolito@evonmedics.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evaristus A Nwulia, MD
Organizational Affiliation
Evon Medics LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanya Alim, MD
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Johnson, MD
Organizational Affiliation
Howard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Fishman, MD
Organizational Affiliation
Maryland Treatment Centers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Serlin, MD
Organizational Affiliation
Family and Medical Counseling Service, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edwin Chapman, MD
Organizational Affiliation
Clinics of Dr. Edwin C. Chapman, MD, PC @ MHDG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics of Dr. Edwin Chapman @ MHDG
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Settles-Reaves
First Name & Middle Initial & Last Name & Degree
Adenuga
First Name & Middle Initial & Last Name & Degree
Edwin Chapman, MD
Facility Name
Family and Medical Counseling Service, Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serlin
First Name & Middle Initial & Last Name & Degree
Jackson
First Name & Middle Initial & Last Name & Degree
Michael Serlin, MD
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rai
First Name & Middle Initial & Last Name & Degree
Hipolito
First Name & Middle Initial & Last Name & Degree
Tanya N Alim, MD
First Name & Middle Initial & Last Name & Degree
Mark Johnson, MD
Facility Name
Maryland Treatment Centers @ Avery Road Treatment Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20853
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenzel
First Name & Middle Initial & Last Name & Degree
Machineni
First Name & Middle Initial & Last Name & Degree
Marc Fishman, MD
First Name & Middle Initial & Last Name & Degree
Kevin Wenzel, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29057388
Citation
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Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder

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