REBOOT for Opioid Abuse

Phase-Based Estimates
1
Effectiveness
1
Safety
San Francisco Department of Public Health, San Francisco, CA
Opioid Abuse+2 More
REBOOT - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether a brief intervention may help reduce overdose and risk behaviors among individuals who have received naloxone.

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Drug Overdose
  • Opiate Overdose

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether REBOOT will improve 6 primary outcomes in patients with Opioid Abuse. Measurement will happen over the course of 16 Months.

16 Months
Dates of substance use treatment
Days of substance use treatment
Modality of substance use treatment
Number of days of opioid use
Number of overdose events
Occurrence of overdose events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Brief Counseling Intervention

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. REBOOT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Brief Counseling Intervention
Behavioral
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 16 months for reporting.

Who is running the study

Principal Investigator
P. C. M.
Phillip Coffin, MIA, MD
San Francisco Department of Public Health

Closest Location

San Francisco Department of Public Health - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-65 years
Characteristics of opioid use history
Previously received take-home naloxone
No life-threatening illness likely to progress clinically during trial
Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule

Patient Q&A Section

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

What does reboot usually treat?

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This review provides a baseline for evaluating the effectiveness of treatment that combines opioid antagonists with other medications to treat drug dependence with a view toward reducing the opioid use during the first weeks after treatment entry.

Unverified Answer

What is opioid abuse?

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Since its introduction in the 1970s, heroin has become an increasingly popular drug among the population as a cheap alternative to other drugs. The use of heroin and synthetic opioids in the 1980s and 1990s has produced a severe addiction to drug use that is becoming a global problem for society. The National Institute on Drug Abuse, a division of the National Institutes of Health, has published guidelines for those seeking clinical trials using these drugs; clinical trials using these drugs are available. Please see https://www.clinicaltrials.gov/ct2/show/NCT00008259 for clinical trials on all four opioid drugs (morphine (heroin), hydrocodone, heroin, and oxycodone).

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What are common treatments for opioid abuse?

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As the national opiate epidemic has continued to decline, this review highlights a growing need to continue the current focus on medication treatment to improve outcomes over and above those achieved through behavioral treatment, detoxification, and rehabilitation.

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What causes opioid abuse?

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Oxymorphone was the only drug used by all subjects in the heroin abuse study. Other opioids were used by some subjects in the other abuse study and morphine (which may be used for non-medical reasons), was not used in the heroin abuse study.\n

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

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At least 1.2 million people (4% of the population) reported illicit opioid use in 2015. Those who had an opioid use disorder had more frequent misuse. In a recent study, findings highlight the need to further examine the use of illicit opioid medications in those who may be at high risk of dependence in a preventive (prevalence) epidemiology sample.

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What are the signs of opioid abuse?

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The signs of opioid abuse are usually nonspecific and include fatigue, depression, loss of appetite, and/or weight loss. The latter two indicators of opioid abuse often occur in conjunction with other signs and symptoms resulting in a constellation of symptoms known as the triangle of death. Clinicians need to be aware of the signs of opioids, including those of the abuse/misuse/dependence spectrum, to ensure that patients receive proper, appropriate treatment.

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Can opioid abuse be cured?

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Despite considerable evidence for the impact of drug abuse on healthcare utilization, drug rehabilitation services frequently focus on only the immediate benefit of patients experiencing pain. Drug abuse can be effectively integrated into the rest of care and has the potential to significantly improve the health of patients. Additional research is needed to determine the best integration of drug abuse into care and if such integration will reduce utilization.

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How does reboot work?

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Users of Reboot had a lower rate of opioid abuse than control group participants, indicating that Reboot offers an additional option for patients trying to avoid opioid abuse.

Unverified Answer

What is the latest research for opioid abuse?

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There are limited studies on the relationship between alcohol and opioid abuse and abuse. Therefore, there remains a gap in the research that exists for both heavy drinkers with opioid abuse and/or abuse, and individuals who use opioids to self-injure. It is clear, however, that individuals who use opioids are more physically active than alcoholics. Thus, exercise should be encouraged for all individuals and should incorporate activities for recovery which is tailored to individuals with substance use.

Unverified Answer

What are the latest developments in reboot for therapeutic use?

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Combining pre-clinical and clinical data shows strong evidence that the combination of a GRas antagonist with opioid antagonists/antagonists has the potential for a unique and effective pain relief solution. Moreover, with pre-clinical data demonstrating safety and an ability for such a combination to decrease the use of opioids, this novel combination has potentially profound public health impact.

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Is reboot safe for people?

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In this small cohort of adolescents who had a positive titer, no new seroconversion and no adverse events were documented, suggesting that in the majority of adolescents who are seronegative at baseline, they are able to reinfect after cessation of the drug. The majority (90%) of adolescents were compliant with treatment, suggesting an acceptable method of adherence. The use of reinfection at least 2 years posttreatment did not result in an increase in seroconversion. The risk of reinfection may be higher for those who smoke and/or have concurrent chronic infections or who begin treatment on or within 60 days prior to the initial infection.

Unverified Answer

Have there been any new discoveries for treating opioid abuse?

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There is still much to learn about treatments for OUD, but it seems likely that non-opioid interventions will continue to be critical and important in helping OUD patients avoid the escalation of their problem and other substance-related problems. OUD remains a dilemma that requires improved treatment research and development to reduce prevalence as much as possible.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Opioid Abuse by sharing your contact details with the study coordinator.