This trial is evaluating whether Buprenorphine/naloxone will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Opioid Abuse. Measurement will happen over the course of 7 days.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. Buprenorphine/naloxone 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 and are in the first stage of evaluation with people.
About 5% of the American adult population take, use, or abuse opioids at any given time. Each year, an average of 8.9 million Americans take opioids for a variety of reasons. More than 18 million Americans will start abusing opioids within the year, a rate of 5.9%. The rate of abuse in the United States will increase the more frequently opioids are prescribed.
Abusers show more severe psychological problems, more frequently abuse drugs other than prescription opioids. In addition, they report more frequent psychological consequences than nonabusers, although they do not experience fewer physical health difficulties.
There is only one effective treatment to cure opioid addiction and to prevent it from occurring again: abstinence. However, since opioid treatment centers only offer treatment to addicts and not healthy people, it is not feasible to treat opioid addictry in the wider society. Nevertheless, a significant number of addicts has succeeded in a [treatment center with the aim of obtaining permanent abstinence and staying clean for life; this procedure is called treatment oriented permanent abstinence, TOPA, program in English] and this approach to treatment is still under development and used only in a few places around the world. Although TOPA is promising for treating the addiction of other drugs as well as that of opioids, further research is necessary before it can become a global procedure.
Opioid abuse is a major public health problem and affects most adults and youth in the USA. Symptoms of opioid abuse typically appear during or following opioid use. Symptoms can be severe and include\nhyperalgesia, hyper- and hypoesthesia, increased sweating, insomnia, confusion, panic attacks, and hallucinations. These symptoms can result in physical abnormalities, including increased heart rate, hypertension, and increased breathing rate. Those affected by opioid abuse may be tempted by their symptomatic relief from their addiction to take unscheduled doses prescribed by their physician (i.e. codeine, oxycodone, heroin). These unsupervised doses can lead to severe opioid-related adverse effects, including\ndeath from overdose.
There are several different therapeutic approaches used by family physicians to address prescription opioid addiction. A variety of medical and psychological strategies are used by physicians to treat opioid addiction in their patients. The treatment of chronic pain with an opioid-based opioid replacement therapy and opioid substitution therapy continue to be the preferred methods for opioid addiction treatment.
Buprenorphine/naloxone combination therapy was more effective than buprenorphine monotherapy at decreasing opioid-induced withdrawal in a rat model. Buprenorphine/naloxone combination therapy was equally effective as naloxone. The withdrawal alleviation is due to the agonism of naloxone, which inhibits the opioid withdrawal effect of mu-opioid receptors.
Participants were generally satisfied with the study, found it a good intervention, the B/N kit was a good investment for reducing drug use, no serious side effects were reported, and participants reported greater confidence that they had completed abstinence. However, it is not known whether B/N kit use is associated with increased risk of relapse.
This systematic review provides comprehensive evidence that the safety of buprenorphine/naloxone treatment in people with drug use disorder is not compromised. Although further rigorous clinical trials are needed to confirm this finding for certain subgroups, buprenorphine/naloxone can have a place in the treatment of people with opioid dependence.
There has been no comparative buprenorphine/naloxone clinical trial in which participants received buprenorphine/naloxone or a placebo. Therefore, no conclusive evidence could be drawn as to whether the buprenorphine/naloxone combination can effectively treat or prevent opioid abuse.
The most commonly used routes of administration in this study include [inserting the needle into the nose (35%), placing the tablet under the tongue (42%), or the oral route (20%)]\n. The majority of buprenorphine users [65% of addicts] would prefer to use the nasal route of administration. Data from a recent study highlights the necessity to educate non-drug users on the importance of proper buprenorphine/naloxone use. Therefore, it is important to implement buprenorphine as a part of the treatment plan and educate clients when they first begin using buprenorphine/naloxone for their pain management.
Findings from a recent study supports the use of Buprenorphin/naloxone and buprenorphine/naloxone maintenance treatment for heroin dependent patients seeking treatment. The efficacy of these treatments justifies a higher dose of these treatments and justifies the use of other pharmaceuticals for maintenance treatment.