CLINICAL TRIAL

Buprenorphine for Opioid Abuse

Waitlist Available · 18+ · All Sexes · West Haven, CT

This study is evaluating whether buprenorphine can be used to treat opioid dependence in veterans.

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About the trial for Opioid Abuse

Eligible Conditions
Opioid Dependence · Opioid-Related Disorders

Treatment Groups

This trial involves 2 different treatments. Buprenorphine is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Buprenorphine
DRUG
Experimental Group 2
Buprenorphine
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
FDA approved

Side Effect Profile for OL Buprenorphine HCl Buccal Film

OL Buprenorphine HCl Buccal Film
Show all side effects
17%
Nausea
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
0%
Venous insufficiency
0%
Abscess limb
0%
Non-cardiac chest pain
0%
Abdominal pain upper
0%
Pancreatitis relapsing
0%
Chronic obstructive pulmonary disease
0%
Kidney infection
0%
Coronary artery disease
0%
Pulmonary contusion
0%
Arthropod bite
0%
Dehydration
0%
Cholecystitis
0%
Pneumonia staphylococcal
0%
Chest pain
0%
Dysarthria
0%
Transient ischaemic attack
0%
Myocardial infarction
0%
Tachycardia
0%
Angina pectoris
0%
Pneumonia
0%
Atrial flutter
0%
Ileus
0%
Impaired healing
0%
Cellulitis
Nausea
17%
Constipation
8%
Vomiting
7%
Headache
7%
Dizziness
5%
Somnolence
5%
Drug withdrawal syndrome
1%
Venous insufficiency
0%
Abscess limb
0%
Non-cardiac chest pain
0%
Abdominal pain upper
0%
Pancreatitis relapsing
0%
Chronic obstructive pulmonary disease
0%
Kidney infection
0%
Coronary artery disease
0%
Pulmonary contusion
0%
Arthropod bite
0%
Dehydration
0%
Cholecystitis
0%
Pneumonia staphylococcal
0%
Chest pain
0%
Dysarthria
0%
Transient ischaemic attack
0%
Myocardial infarction
0%
Tachycardia
0%
Angina pectoris
0%
Pneumonia
0%
Atrial flutter
0%
Ileus
0%
Impaired healing
0%
Cellulitis
0%
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01675167) in the OL Buprenorphine HCl Buccal Film ARM group. Side effects include: Nausea with 17%, Constipation with 8%, Vomiting with 7%, Headache with 7%, Dizziness with 5%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
their This study aimed to assess the willingness of pregnant women to be detoxified from opioids for buprenorphine maintenance. show original
women of childbearing age who don't want to get pregnant will use contraception during the study, and will have pregnancy tests every month. show original
We are looking for males and females between the ages of 18 and 65 who are currently dependent on prescription opioids, have a documented history of opioid dependence, signs of opiate withdrawal, and a positive urine toxicology for opiates. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 0-12
Screening: ~3 weeks
Treatment: Varies
Reporting: Weeks 0-12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 0-12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Buprenorphine will improve 1 primary outcome in patients with Opioid Abuse. Measurement will happen over the course of Weeks 0-12.

Change in Timeline Follow-Back (TLFB) assessment
WEEKS 0-12
Will be used to document the degree of daily opioid consumption and to monitor the use of other substances during the 12 weeks of treatment.
WEEKS 0-12

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 causes opioid abuse?

We found the strongest predictor of opioid abuse is psychiatric illness. Other variables that were found significant in our analysis included gender, ethnicity, and substance use. Sociodemographic factors and mental health services should be systematically studied as possible risk factors for potential opioid abuse. Clinicians can work with patients and their families to identify signs and symptoms of potential opioid abuse and evaluate the patient's risk for abuse. We recommend careful treatment of psychiatric disease (e.g., depression, psychosis) with benzodiazepines or other anti-anxiety agents to decrease the risk of abuse.

Anonymous Patient Answer

What are the signs of opioid abuse?

Abstinence is the hallmark of opioid abuse, including an objective withdrawal syndrome that occurs abruptly and may be severe. The signs and symptoms of opioid abuse are diverse and nonspecific, but they are not necessarily present in every case of withdrawal. The constellation of signs and symptoms of opioid withdrawal can be life-threatening. If withdrawal symptoms occur and do not improve, then the use of opioids should be discontinued or alternative treatments should be considered. Opioid abuse can be managed, but withdrawal is a major medical emergency requiring immediate medical attention.

Anonymous Patient Answer

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

A considerable number of drug abusers receive emergency treatment for opioid and other drug-related trauma: the total amount of time spent in a hospital, rehabilitation facility, jail, and/or probation detention may exceed 50 percent of their days in hospital when these abusers are not in a state hospital. Thus in addition to a substantial number of deaths resulting from opioid use, many of the victims and their families will endure long periods of time of grief, and may be profoundly affected in the future by physical and/or psychological trauma, particularly in child-bearing years, when the greatest number of fatalities occur.

Anonymous Patient Answer

What is opioid abuse?

Opioid abuse is defined as the use of prescription or non-prescription prescription and non-medical prescription opioid drugs, including pills, by persons who have never used non-medical opioid drugs. It is estimated that over 18 million adults misuse prescription, non-prescription, or both opioids. The magnitude of the problem appears to be rising in all parts of the country. There is a strong and growing need for research to clarify treatment options for the thousands of people who misuse prescription opioids, particularly those in treatment for substance use disorders. Drug treatment should consider an individual patient, including the specifics of history and pharmacodynamic and pharmacokinetic properties of the intended treatment, available clinical trials, and any contraindications and drug-drug interactions.

Anonymous Patient Answer

What are common treatments for opioid abuse?

Current treatments for opioid abuse include methadone maintenance treatment and other medication-assisted treatment (MAT) programs. Treatment varies from outpatient treatment to inpatient or residential treatment. There is some evidence that those undergoing MAT demonstrate greater substance use abstinence and social integration and fewer negative social consequences, compared to those not receiving MAT treatment. More research is needed to understand the effects of MAT for cocaine and opiate use and on the long-term prognosis. This may provide information on which populations are at risk of further social consequences to drug abuse and may assist in developing treatment strategies.

Anonymous Patient Answer

Can opioid abuse be cured?

A very small percentage of opioid abusers are able to completely halt all usage of opioids. However, other than the aforementioned case of complete abstinence, it is impossible using available evidence-based guidelines, to make a definitive claim that all opioid abusers can abstain completely from opioids. To do so, one would need to perform a larger, randomized controlled trial than the one that resulted in the aforementioned case.

Anonymous Patient Answer

What is the latest research for opioid abuse?

The use of naloxone and buprenorphine, a prolonged-infusion form of naloxone, are promising pharmacotherapies to help opiate abusers manage and curb their addiction. There are also studies in progress to develop better, more-targeted opioid therapeutics. There is also a strong effort to develop an injectable form of buprenorphine in hopes of reducing serious opioid-related medical issues like infections, needle and syringe transmission, and withdrawal syndromes. The most recent opioid abuse treatment is the opioid antagonist naltrexone. More trials utilizing naltrexone to treat opioid abuse are planned in the future.

Anonymous Patient Answer

What does buprenorphine usually treat?

We found that buprenorphine is often prescribed to treat pain, withdrawal symptoms, and other conditions unrelated to its known approved uses, leading to an alarming level of opioid misuse and addiction.

Anonymous Patient Answer

Who should consider clinical trials for opioid abuse?

Patients can and are often actively seeking a clinical trial of novel treatments for opioid abuse. Clinical trials would benefit from increased awareness of enrollment procedures, as well as from patient education about clinical trial design.

Anonymous Patient Answer

Have there been any new discoveries for treating opioid abuse?

No recent developments occurred in the treatment of heroin and opiate abusers. Only minor successes are reported in the treatment of illicit cocaine abusers. There is no evidence of any new treatments for alcoholics other than one that combines brief motivational interventions combined with drug replacement. There is no compelling evidence that CBT can prevent relapse of an opiate addict. There is evidence that a combination of CBT plus community reinforcement training can be an effective treatment for heroin smokers. There is no evidence of any new treatments other than psychotherapy or drug replacement for the treatment of opioid abuse. The evidence from studies of methadone treatment has been contradictory due to insufficient numbers and inadequate quality of trials.

Anonymous Patient Answer

Does opioid abuse run in families?

In a recent study, findings do not support the notion that opioid abuse runs as a monozygotic trait. Any reports showing inheritance linkage as such would represent spurious associations that would be explained by other genetic or environmental factors.

Anonymous Patient Answer

What is the primary cause of opioid abuse?

The hypothesis that opioid abuse is the result of the combination of genetic and environmental factors, including early experiences, remains a model of opioid use at the most severe levels of use that can be adequately tested and disproved using experimental methods. Given the continuing presence of significant environmental factors in the opioid abuse epidemic, we have developed a comprehensive framework that encompasses the genetic-environmental paradigm and includes specific hypotheses about the contribution of each. This framework also permits empirical test of the key hypotheses and may inform prevention.

Anonymous Patient Answer
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