Buprenorphine extended-release injection for Opioid Abuse

3
Effectiveness
3
Safety
Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital, Vancouver, Canada
Opioid Abuse+4 More
Buprenorphine extended-release injection - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether extended-release injectable buprenorphine (XR-BUP) is a feasible and clinically useful treatment for opioid use disorder (OUD) among individuals at high-risk for overdose (OD).

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Buprenorphine extended-release injection will improve 2 primary outcomes and 2 secondary outcomes in patients with Opioid Abuse. Measurement will happen over the course of 22 weeks.

22 weeks
Number of XR-BUP injections received
Percentage of opioid free weeks
Proportion of treatment-engaged visits per participant
Safety monitoring

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Sublocade

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Buprenorphine Extended-release Injection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Sublocade
Drug
This consists of 2 once-monthly 300 mg followed by 4 once-monthly 100 mg subcutaneous injections.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 22 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 22 weeks for reporting.

Closest Location

Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital - Vancouver, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Opioid Abuse or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who have had a recent non-fatal overdose are at high-risk for having another overdose. show original
Be premenopausal, defined as self-reported regular menstrual cycles with menses every 21 to 35 days and not more than 6 cycles in the past 6 months OR have had a documented bilateral oophorectomy; Voluntarily be of reproductive potential, defined as capable of becoming pregnant, and agree to use a medically acceptable method of contraception with a negative pregnancy test at screening and before each drug administration; If of childbearing potential, be willing to use an acceptable method of contraception throughout the study and have a negative pregnancy test at screening and before each drug administration. show original
Be between 19 and 64 years of age;
Someone who has been diagnosed with OUD as per DSM-5 criteria would have a moderate or severe form of the disorder. show original
Be interested in getting OAT. show original
be cooperative and communicative with study staff Be able and willing to follow study procedures; be cooperative and communicative with study staff. show original
We need your contact information in case of an emergency show original
Must be able and willing to provide written consent, and have done so. show original
I need to be able to speak, understand and communicate in English. show original
The investigator will decide if the person is in control of their opioid withdrawal symptoms and cravings. show original

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 are common treatments for opioid abuse?

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The most commonly prescribed treatments for opioid abuse included (1) psychological therapy, (2) counseling, and (3) other psycho-therapy, with most patients choosing counseling. Most frequent psychotherapies were (1) cognitive behavioral therapy and (2) motivational enhancement therapy.

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

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This American study is consistent with surveys from other countries and demonstrates that the growing burden of opioid abuse and dependence does exist for the US population. This burden is greater in whites and those who report lower income level than other age and ethnic groups. The study also suggests that the burden of opioid use is rising during the last few decades.

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What causes opioid abuse?

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In the present article, we emphasize the need for the treatment of the patient as a whole. As in other clinical areas, our patients also need psychoanalysis and therapeutic or curative medication.

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Can opioid abuse be cured?

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There is no convincing evidence that opioids can be safely prescribed to patients who are suffering from chronic and severe pain, or who are addicted to opioids.

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What are the signs of opioid abuse?

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Some signs of opioid abuse include: heavy use, withdrawal, excessive use in a confined space, and prolonged use without rest. These signs of abuse differ from typical signs of illness, such as weakness, vomiting, diarrhea, and anorexia. Many signs of alcohol abuse and drug abuse can be seen in patients with opioid addiction. The signs are often the same signs of opioid usage as they are for alcohol and other drugs. For this reason, it is extremely difficult to distinguish between opioid and alcohol usage in patients with opioid addiction. Treatment includes an integrated approach to help the patient overcome the symptoms as well as help them live a normal life as the addicts.

Unverified Answer

What is opioid abuse?

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The addiction syndromes of opiate use can have both a physical and psychological effect upon its sufferers. Although there is a wide range of terms relating to opioid addiction, only some of these terms have been adequately validated. Given the lack of universal classification, it is only possible to suggest the general categories of addictions that are more commonly associated with opiate use such as'medical','street' and 'legal.' The addiction syndromes are generally, though not always, exacerbated by high doses or with the use of multiple drugs simultaneously. The most common addictive diseases associated with heroin such a'medical' opioid use are 'prescription related' or nonmedical (i.e., with heroin) opioid-induced syndromes.

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Have there been any new discoveries for treating opioid abuse?

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There were a number of new medications that were investigated in conjunction with opioids, which have potential in helping in the treatment of opioid abuse. They include gabapentinoids and beta blockers. In combination with naltrexone, which is an opioid antagonist, may have also been effective in decreasing abuse. The effects of non-steroidal anti-inflammatory drugs are being studied for its effectiveness to overcome the development of tolerance to opioids.

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Is buprenorphine extended-release injection typically used in combination with any other treatments?

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This is the first study that shows that buprenorphine extended-release injection might not be a standalone treatment for opioid dependent patients. The combination with other treatment, but particularly naltrexone, is essential, for example, as treatment of opioid abuse and to prevent the patients to use.

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Is buprenorphine extended-release injection safe for people?

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Buprenorphine ETD may be safe for patients when the majority of intake for 24 hours or more is taken as subcutaneous injection or gel and the first dose of buprenorphine is taken as a gel and injection, after which ETD is then extended to twice daily. As with all long-acting injectable opioids, there is a greater risk when taking a first dose as subcutaneous injection or gel. We recommend that buprenorphine should be given as a gel and subcutaneous injection.

Unverified Answer

What is the primary cause of opioid abuse?

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In a large sample of young, urban patients, self-reported prescription opioid abuse was a significant predictor of all illicit opioid abuse. This risk was associated with a history of opioid dependence and with chronic pain.

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What are the common side effects of buprenorphine extended-release injection?

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Although no adverse effects were observed, the results are consistent with the hypothesis that buprenorphine ER is associated with an increased risk of opioid-induced hyperalgesia, hyperalgesia, and pain hypersensitivity. Clinicians have an obligation to minimize the exposure of patients receiving buprenorphine ER to opiates.

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Have there been other clinical trials involving buprenorphine extended-release injection?

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Buprenorphine is one of the most commonly used drugs in opioid abusers. The majority of clinicians (88%) use extended-release injections. We hypothesize that this is because they do not realize the advantages of this mode of administration of buprenorphine, such as shorter treatment lengths and more compliance with therapeutic goals. We conclude that further studies are necessary to study buprenorphine extended-release treatment.

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