Opioid Use Disorder, ModeratePhase 2CBOT-OUDNCT04850664

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

A Phase 2 study testing CBOT + TAU in people with Opioid Use Disorder, Moderate and Opioid Use Disorder, Severe, run by Evon Medics LLC at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms
What is being tested?: CBOT + TAU
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 4 sitesUnited States
Study dates: 26 Mar 2021to 31 Dec 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

Evaristus A Nwulia, MD, MHS contact

410-227-2005

enwulia@evonmedics.org

Maria M Hipolito, MD contact

571-241-2766

mhipolito@evonmedics.org

United States4 sites, 4 recruiting

Maryland Treatment Centers @ Avery Road Treatment Center
Rockville, Maryland, 20853
Wenzel
Machineni
Recruiting
Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, 20002
Settles-Reaves
Adenuga
Recruiting
Family and Medical Counseling Service, Inc
Washington D.C., District of Columbia, 20020
Serlin
Jackson
Recruiting
Howard University
Washington D.C., District of Columbia, 20060
Rai
Hipolito
Recruiting

Other trials in United States

About this study

Official title: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder

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.

Read the 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.

Conditions: Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms, Craving, Negative Affectivity
Being tested: CBOT + TAU, Sham + TAU
Keywords: Opioid Use Disorders, Buprenorphine Maintenance Treatment, Orbitofrontal cortex (OFC), CBOT, Relapse Prevention
Medical subject headings: Opioid-Related Disorders, Lymphoma, Follicular, Substance Withdrawal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBOT + TAUDrug
Also called plant based essential oils
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.
Sham + TAUDrug
Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.

Study groups in NCT04850664
Study group	Role	What they receive
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). Receives: 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). Receives: Drug: Sham + TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening visit to Week 24

Secondary outcomes (7)

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.
Measured: Screening visit to Week 12
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).
Measured: Screening visit to Week 2
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).
Measured: Week 12 to Week 13
Pre-Intervention changes in OCS from Screening to Week 2
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Measured: Screening visit to Week 2
Post-Intervention changes in OCS from Week 12 to Week 13
a modification of the Cocaine Craving Scale was used to measure opioid craving.
Measured: Week 12 to Week 13
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.
Measured: Screening visit to Week 2
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.
Measured: Week 12 to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202131 Dec 2022

First posted20 Apr 2021
Study start26 Mar 2021
Primary completion30 Nov 2022 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Opioid Use Disorder, ModerateStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04850664
Sponsor's protocol ID: CBOTDA049616
Other IDs: 2R44DA049616-02
Acronym: CBOT-OUD
Status last verified: Jul 2021
First submitted: 8 Mar 2021
Last updated: 6 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29057388
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.
PubMed 10731226
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.
PubMed 25042581
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.
PubMed 4894805
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.
PubMed 19235739

Want to know more?

Evaristus A Nwulia, MD, MHS

410-227-2005

enwulia@evonmedics.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder
ClinicalTrials.gov ID: NCT04850664
Acronym / sponsor ID: CBOT-OUD / CBOTDA049616
Conditions: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 190 participants (estimated)
Lead sponsor: Evon Medics LLCIndustry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA), Howard University, Family and Medical Counseling Service, Inc, Maryland Treatment Centers, Inc., Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
Study start: 26 Mar 2021 (actual)
Primary completion: 30 Nov 2022 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 20 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
CBOT + TAU	Experimental	Drug: CBOT + TAUCBOT 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 + TAU	Sham comparator	Drug: Sham + TAUSham 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).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBOT + TAUAlso: plant based essential oilsThe 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.	Drug	CBOT + TAU
Sham + TAUSham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.	Drug	Sham + TAU

Primary outcome

6-month buprenorphine maintenance treatment (BMT) retention
Time frame: 2 weeks after baseline
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
Time frame: 4 weeks after baseline
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
Time frame: 6 weeks after baseline
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
Time frame: 8 weeks after baseline
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
Time frame: 10 weeks after baseline
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
Time frame: 12 weeks after baseline
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
Time frame: 14 weeks after baseline
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
Time frame: 16 weeks after baseline
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
Time frame: 18 weeks after baseline
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
Time frame: 20 weeks after baseline
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
Time frame: 22 weeks after baseline
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
Time frame: 24 weeks after baseline
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
Time frame: 26 weeks after baseline
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
Time frame: 28 weeks after baseline
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
Time frame: 30 weeks after baseline
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
Time frame: 32 weeks after baseline
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
Time frame: 34 weeks after baseline
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
Time frame: 36 weeks after baseline
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
Time frame: Screening to Week 12 Treatment
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
Time frame: Screening to 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
Time frame: Screening visit to Week 12
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
Time frame: Screening visit to Week 24
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
Time frame: Screening visit to Week 12
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
Time frame: Screening visit to Week 24
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.

7 secondary outcomes

Opioid Relapse
Time frame: Screening visit to Week 12
Pre-Intervention changes in SOWS from Screening at Week 2
Time frame: Screening visit to Week 2
Post-Intervention changes in SOWS from Week 12 at Week 13
Time frame: Week 12 to Week 13
Pre-Intervention changes in OCS from Screening to Week 2
Time frame: Screening visit to Week 2
Post-Intervention changes in OCS from Week 12 to Week 13
Time frame: Week 12 to Week 13
Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2
Time frame: Screening visit to Week 2
Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
Time frame: Week 12 to Week 13

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
Background: PubMed 29057388Jackson 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.
Background: PubMed 10731226Volkow 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.
Background: PubMed 25042581Lucantonio 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.
Background: PubMed 4894805Temple 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.
Background: PubMed 19235739Hummel 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evaristus A Nwulia, MD, MHS contact

410-227-2005

enwulia@evonmedics.org

Maria M Hipolito, MD contact

571-241-2766

mhipolito@evonmedics.org

Evaristus A Nwulia, MD principal investigator

Evon Medics LLC

Tanya Alim, MD principal investigator

Howard University

Mark Johnson, MD principal investigator

Howard University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBOT + TAU in people with Opioid Use Disorder, Moderate and Opioid Use Disorder, Severe, run by Evon Medics LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Evaristus A Nwulia, MD, MHS (410-227-2005, enwulia@evonmedics.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month buprenorphine maintenance treatment (BMT) retention (time frame: 2 weeks after baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04850664, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.