CBOT + TAU for Craving

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Howard University, Washington, United States
Craving+8 More
CBOT + TAU - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a brain stimulation device can help people with opioid use disorders stay in treatment.

See full description

Eligible Conditions

  • Craving
  • Opioid Use Disorder, Moderate
  • Withdrawal Symptoms
  • Negative Affectivity
  • Opioid Use Disorder, Severe

Treatment Effectiveness

Study Objectives

This trial is evaluating whether CBOT + TAU will improve 6 primary outcomes and 7 secondary outcomes in patients with Craving. Measurement will happen over the course of Screening visit to Week 2.

36 weeks after baseline
6-month buprenorphine maintenance treatment (BMT) retention
Week 12
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week
Screening to Week 24
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24
Week 12
Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month
Opioid Relapse
Week 2
Pre-Intervention changes in OCS from Screening to Week 2
Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2
Pre-Intervention changes in SOWS from Screening at Week 2
Week 24
Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month
Change from Screening in negative affect severity in the PANAS
Week 13
Post-Intervention changes in OCS from Week 12 to Week 13
Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
Post-Intervention changes in SOWS from Week 12 at Week 13

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

CBOT + TAU
1 of 2
Sham + TAU
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 190 total participants across 2 different treatment groups

This trial involves 2 different treatments. CBOT + TAU is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

CBOT + TAU
Drug
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).
Sham + TAU
Drug
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).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 to week 13
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 to week 13 for reporting.

Who is running the study

Principal Investigator
E. A. N.
Evaristus Awele Nwulia, Chief Scientific Officer
Evon Medics LLC

Closest Location

Howard University - Washington, United States

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Craving or one of the other 8 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
Have a place to stay when receiving the intervention.

Patient Q&A Section

What causes opioid abuse?

"Opioid use is a major and frequent cause of death in the United States. Alcohol and marijuana use may also contribute to the frequency and complexity of opioid use and abuse. The major route of opiate use is through the sale or diversion of illicit pharmaceutical drugs, particularly morphine, methadone and heroin. Drug users face multiple social and health disparities. As opioid use increases, the rate of misuse and abuse increases. Effective treatment and prevention programs could have the most benefit. Educational and economic information is vital for mitigating the harm of opioid use. Understanding that individuals who choose these drugs are at greater risk of abuse has an important role in treatment and prevention programs." - Anonymous Online Contributor

Unverified Answer

Can opioid abuse be cured?

"It is impossible to cure opioid abusers. The idea of eradicating their addiction is unrealistic and, in general, this is an unrewarding path for the individual and for public health policy. To the extent that an addict might be cured, the effect will be negligible." - Anonymous Online Contributor

Unverified Answer

What are common treatments for opioid abuse?

"About half of opioid abusers abuse prescription opioids, which suggests use of these drugs is a highly prevalent issue. More than one in four addicts in a one-year period had been in treatment for more than one year and one out of five abuse is for nonmedical purposes. While a large majority of addicts are aware of the negative impacts of their misuse, little of the available evidence-based treatments are being offered in outpatient rehabilitation for illicit drug problems. Effective and sustained intervention programs focusing on pharmacotherapeutic components are needed." - Anonymous Online Contributor

Unverified Answer

What are the signs of opioid abuse?

"This report provides a compendium of common signs of opioid abuse and a basic guide and algorithm for the clinical detection of indicators of opioid abuse. Further studies are needed that assess other possible signs of opioid abuse outside of common signs." - Anonymous Online Contributor

Unverified Answer

How many people get opioid abuse a year in the United States?

"About 11.4 million people in the United States receive treatment at least once yearly for opioid abuse while 3.3 million get diagnosed annually. This is a substantial number for those who get this kind of treatment." - Anonymous Online Contributor

Unverified Answer

Is cbot + tau typically used in combination with any other treatments?

"The CBT + tau combination appears to be safe and effective with little difference in the rate of recidive psychosis (relative risk) compared to either individual treatment in a large, prospective, open-label, unblinded trial." - Anonymous Online Contributor

Unverified Answer

What is opioid abuse?

"The prevalence of opioid abuse in Canada is high. Although some patients use opioids strictly for medical reasons and others for recreational purposes, the majority of patients in the study were abusing opioids for reasons other than medical ones. This report demonstrates the need for a national system of prescription reporting, in the hopes that this information will lead to more adequate public education and policy." - Anonymous Online Contributor

Unverified Answer

How does cbot + tau work?

"Results from a recent paper demonstrate that Cbot + tau effectively controlled, and provided a significant benefit in terms of pain relief, in patients with peripheral neuropathy secondary to chronic diabetic foot ulcer. The addition of Cbot + tau is most effective in individuals with poor kidney function and those on diuretics." - Anonymous Online Contributor

Unverified Answer

What does cbot + tau usually treat?

"There are no medications currently approved by the FDA for the treatment of BZD abuse. Combinations of bupropion and a taurine derivative such as CBT + Tau have been reported to be effective in treating BZD abuse at least in part by decreasing the dopamine levels within the brain. However, more studies are needed. It is important to understand that CBT + Tau does treat BZD. However, it probably is not going to be a cure. BZD use is the strongest drug risk factor for drug addiction and overdose of a pharmaceutical; thus, the use of CBT + Tau is only a first step toward a drug abuse treatment." - Anonymous Online Contributor

Unverified Answer

Does opioid abuse run in families?

"Although these findings are intriguing as they underscore the potential importance of environmental factors and genes for the etiology of addictive behavior, the evidence also points to the need to be cautious in interpreting and comparing family and cohort studies of liability for prescription drug abuse." - Anonymous Online Contributor

Unverified Answer

Has cbot + tau proven to be more effective than a placebo?

"The present trial does not refute a possible clinical superiority of combined buprenorphine/naloxone over a placebo with respect to treatment of pain associated with opiate dependence. The findings have to be validated in a further study with a relatively bigger sample sized." - Anonymous Online Contributor

Unverified Answer

Is cbot + tau safe for people?

"There was no evidence of an increased risk of overdose with CBOT+Tau use or a significantly reduced risk of overdose with RIGA use. This may be because those at risk with a previous overdose were unlikely to use the treatments on subsequent occasions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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