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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44DA049616-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Howard University | OTHER |
| Family and Medical Counseling Service, Inc | UNKNOWN |
| Maryland Treatment Centers @ ARTC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBOT + TAU | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evaristus A Nwulia, MD, MHS | Contact | 410-227-2005 | enwulia@evonmedics.org | |
| Maria M Hipolito, MD | Contact | 571-241-2766 | mhipolito@evonmedics.org |
| Name | Affiliation | Role |
|---|---|---|
| Evaristus A Nwulia, MD | Evon Medics LLC | Principal Investigator |
| Tanya Alim, MD | Howard University | Principal Investigator |
| Mark Johnson, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics of Dr. Edwin Chapman @ MHDG | Recruiting | Washington D.C. | District of Columbia | 20002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29057388 | Background | 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. | |
| 10731226 | Background | 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. |
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| UNKNOWN |
| Clinics of Dr. Edwin Chapman, MD, PC @ MHDG | UNKNOWN |
Evon Medics will perform randomization of participants stratified by sex at site level. Site staff and participants will be blinded to treatment assignment.
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| Sham + TAU | Drug | Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks. |
|
| 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 |
| 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). | 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). | 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. | 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. | 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. | 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. | Week 12 to Week 13 |
| 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 |
| Family and Medical Counseling Service, Inc | Recruiting | Washington D.C. | District of Columbia | 20020 | United States |
|
| Howard University | Recruiting | Washington D.C. | District of Columbia | 20060 | United States |
|
| Maryland Treatment Centers @ Avery Road Treatment Center | Recruiting | Rockville | Maryland | 20853 | United States |
|
| 25042581 | Background | 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. |
| 4894805 | Background | 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. |
| 19235739 | Background | 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. |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D008224 | Lymphoma, Follicular |
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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