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Behavioural Intervention
CBOT + TAU for Opioid Use Disorder (CBOT-OUD Trial)
Phase 2
Waitlist Available
Led By Marc Fishman, MD
Research Sponsored by Evon Medics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 13
Awards & highlights
Summary
This trial will establish the effectiveness of a brain stimulation system in reducing symptoms of opioid withdrawal and reducing negative affect in people with OUDs.
Eligible Conditions
- Opioid Use Disorder
- Withdrawal
- Craving
- Negative Affect
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12 to week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-month buprenorphine maintenance treatment (BMT) retention
Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month
Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month
+3 moreSecondary outcome measures
Opioid Relapse
Post-Intervention changes in OCS from Week 12 to Week 13
Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBOT + TAUExperimental Treatment1 Intervention
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).
Group II: Sham + TAUPlacebo Group1 Intervention
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).
Find a Location
Who is running the clinical trial?
Howard UniversityOTHER
42 Previous Clinical Trials
14,799 Total Patients Enrolled
Family and Medical Counseling Service, IncUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
Maryland Treatment Centers @ ARTCUNKNOWN
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