Buprenorphine: Frequency Group for Opioid Abuse

High Risk Obstetrical Consultants, Knoxville, TN
Opioid Abuse+2 More
Buprenorphine: Frequency Group - Drug
18 - 65
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether a reduction in the amount of buprenorphine given to pregnant women will help reduce the risk of withdrawal in newborns.

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Pregnant State
  • Opiate Addiction

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Buprenorphine: Frequency Group will improve 6 primary outcomes and 1 secondary outcome in patients with Opioid Abuse. Measurement will happen over the course of 4.5 years.

4.5 years
Clinical Opioid Withdrawal Scale (COWS) scores
Plasma levels of buprenorphine + metabolites, neurotransmitters (serotonin, dopamine and nor-adrenaline), and cotinine
Subjective Opioid Withdrawal Scale (SOWS) scores
Urine toxicology screen
Visual Analog Scale (VAS) Scores
Weekly Follow-up Form
Weekly Smoking and Alcohol Use Form

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Buprenorphine Magnitude Group

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. Buprenorphine: Frequency Group is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Buprenorphine Magnitude GroupSubjects will receive alternating reductions of 1 mg and then 2 mg weekly. Subjects on TID or QID dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Buprenorphine Frequency GroupSubjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. Subjects on TID or QID dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Buprenorphine Dosing Group
Subjects will receive dose reductions identical to either the Magnitude (alternating 1 and 2 mg reductions) or Frequency (2 mg reductions on alternating 1 and 2 week intervals) groups. Subjects on BID dosing, as prescribed by their MAT provider, will be assigned to the Dosing group (n=10).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4.5 years for reporting.

Closest Location

High Risk Obstetrical Consultants - Knoxville, TN

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Singleton gestation between 14-35 weeks
On a stable BUP dose (for at least 2 weeks) through a MAT program or just starting BUP therapy through a MAT program.
Willingness to consent to the study and for those on a stable BUP dose, willingness to experience mild, temporary withdrawal symptoms

Patient Q&A Section

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

Can opioid abuse be cured?

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Data from a recent study of this investigation suggest that it should not be possible to treat opiate addiction. A curative treatment does not exist, and the risk of relapse and of death is very high even if the underlying problem is addressed.

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What is opioid abuse?

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Opioid abuse is a growing public health problem in which the harm in individual cases may be outweighed by the risks of addiction, especially when the prescription drug concerned is highly effective and with relatively little abuse potential (such as heroin and oxyContin) - but it rarely is for the sake of the individual abuse. This problem is likely to increase, especially among older patients with chronic medical conditions.

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What causes opioid abuse?

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Results from a recent paper supports the notion that genetic variants associated with opioid use predispose individuals to the development of opioid abuse and dependence, and may be associated with both of these outcomes and a variety of other drug-related behaviors.

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What are the signs of opioid abuse?

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Withdrawal of opioids is associated with fatigue, dizziness, and increased sweating and may sometimes cause a loss in consciousness. The opioid-induced pruritus is highly noticeable in those with chronic opioid use or opioid abuse.

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

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Opioid abuse is a national epidemic in the United States with widespread prevalence and devastating impact on individual and societal well-being. Efforts that have been made toward prevention of opioid abuse include improved use of alternative [pain management](https://www.withpower.com/clinical-trials/pain-management) strategies, such as acetaminophen (paracetamol) and NSAIDs, which have been recommended in NINDS pain treatment guidelines, as well as a variety of educational tools disseminated regularly through the medical and media press. Data are sparse, however, regarding the extent that these interventions have altered opioid usage patterns, and no definitive conclusions have been drawn regarding their impact. Additional studies in a larger, more diverse population are required to understand best practices and devise strategies for improving the nation's opioid utilization patterns.

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What are common treatments for opioid abuse?

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Most current treatments for opioid abuse are based on behavioural intervention and rely on the use of naltrexone and methadone. Those who do not respond to naltrexone and methadone frequently relapse on to illegal heroin use or heroin replacement. For this reason, treatment with naltrexone and methadone may prove ineffective, and alternative treatments are now being looked to as part of the management of opioid problems. Drugs commonly used for the maintenance of opioid dependence include buprenorphine (Subutex) and a number of other opioid maintenance agents.

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Does opioid abuse run in families?

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The data do not support evidence that family history of opioid abuse is associated with a history of drug addiction or with any psychiatric or other medical diagnoses. Although family members of opioid abusers report use of illicit opioids, these data show low rates of abuse and dependence among family members.

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Is buprenorphine: frequency group typically used in combination with any other treatments?

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The data are indicative of an opioid dependence-free buprenorphine protocol. Although a significant number of treatment completers stopped buprenorphine completely, buprenorphine may still be a treatment option for opioid withdrawal-positive patients. It is essential to review all available clinical research literature, in addition to the results of individual patient studies that are used to support any recommendation for, or withdrawal of, buprenorphine. Clinicians in the buprenorphine treatment community must take into account the importance of the following points and the potential for the patient to receive and tolerate buprenorphine treatment.

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Have there been other clinical trials involving buprenorphine: frequency group?

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This is the first report comparing the effect of buprenorphine at low dose with other buprenorphine treatment modalities (such as sublingual buprenorphine). Previous studies involving buprinorphine at higher doses compared it to naloxone, but this was a comparison of two groups of [malfunctioning patients]. No comparative clinical trial has been reported comparing buprenorphine and nalmefene in the treatment of methadone-maintenance patients, and future clinical trials will need to replicate these results.

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Who should consider clinical trials for opioid abuse?

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Patients with a long interval between the cessation of opioid use and the onset of clinical trials may be at higher risk for relapse during clinical trials (median 24 months). Such patients can be considered for clinical trials but with a higher risk for relapse during drug testing. At the same time, patients with a short latency period (<3 months) before onset of clinical trials and low methadone maintenance treatment (MMT) compliance are most likely to respond well to clinical trials. This information is especially important due consideration of the risk-benefit tradeoff of a therapy targeted only to those at a higher risk of relapse.

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Is buprenorphine: frequency group safe for people?

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Evidence does not indicate that people are more likely to be dependent or stop taking medication under the influence of a group of friends. In the short-term, the members of frequency groups appear to suffer from withdrawal from medication, less frequently than non-exposed group members. There has not been sufficient time and research quality to fully address the long-term health consequences. Nevertheless, we consider the use of buprenorphine:frequency groups to be safe and in the public interest.

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Does buprenorphine: frequency group improve quality of life for those with opioid abuse?

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These participants reported decreased opioid use over a 6-month post-treatment period, a positive effect on QOL. In a recent study, findings have practical ramifications for a variety of healthcare providers.

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