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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
Age 18- 70years
Diagnosis of current moderate or severe OUD in the past 6 months, including the past one month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 13
Awards & highlights

CBOT-OUD Trial 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

CBOT-OUD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CBOT-OUD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 13 for reporting.

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 more
Secondary 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 more

CBOT-OUD Trial 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?

Maryland Treatment Centers @ ARTCUNKNOWN
Clinics of Dr. Edwin Chapman, MD, PC @ MHDGUNKNOWN
Howard UniversityOTHER
39 Previous Clinical Trials
13,057 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients would be able to join this clinical trial?

"This study is looking for 190 people with cravings aged 18 to 70. The most important criteria for applicants are as follows: being willing to receive study interventions and buprenorphine during the study, not meeting criteria for current moderate or severe use of other substance abuse disorders (except nicotine), age 18-70 years, diagnosis of current moderate or severe OUD in the past 6 months including the past one month, diagnosis of Major Depressive Disorder, Anxiety disorders, and Post-traumatic Stress Disorder included as long as symptoms are stable with no suicidal ideation or plans and no recent changes in treatment within the last 6 weeks prior"

Answered by AI

Are there any unfilled spots in this study that patients could occupy?

"That is correct. The clinicaltrials.gov website lists this trial as recruiting, with the original posting on March 26th, 2021 and the most recent update being July 30th, 2021. There are 4 locations for this study looking to enroll a total of 190 participants."

Answered by AI

Does this research allow for people who are under 40 years old to participate?

"The age range for participants in this study is 18 to 70 years old."

Answered by AI

Are there risks associated with CBOT + TAU treatment?

"There is some evidence backing up CBOT + TAU's safety, but not its efficacy. Consequently, it received a score of 2."

Answered by AI

What was the motivation for conducting this research?

"The primary goal for this study, which will be assessed over a 6-month period, is to observe negative affect severity in the PANAS. Additionally, researchers will monitor changes in opioid craving and withdrawal symptoms as well as relapse rates."

Answered by AI

How many people are participating in this experiment at most?

"The information available on clinicaltrials.gov verifies that this experiment is still actively recruiting patients. This research project was originally published on March 26th, 2021 and was most recently updated on July 30th, 2021. In total, the study needs 190 individuals from 4 different locations."

Answered by AI
~47 spots leftby Apr 2025