A Phase 2 interventional study of CBOT + TAU and Sham + TAU in Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe and Withdrawal Symptoms, sponsored by Evon Medics LLC. Status unknown at 4 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Evon Medics LLC · Phase 2, Interventional, and Prevention
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.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's planned enrollment of 190 is above the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Evon Medics LLC is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 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
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
Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening visit to Week 24
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12 to Week 13
Plan to share: No
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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