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Nicotine Clinical Trials: Why Aren’t There Any

The most common issues surrounding nicotine addiction

There is no known clinical trial exploring the use of nicotine for “addiction.” In other words, there has been no study conducted on the use of pure nicotine in non-smokers to determine whether or not it might be addictive.

There have been several clinical trials in which nicotine has been given to non-smokers for other reasons, such as studying its potential benefits in treating specific medical conditions.

To date, eight trials have been published involving hundreds of never-smokers. In some cases, large doses of nicotine were given every day for several months. No subject in any study was reported to have exhibited any sign of reinforcement or withdrawal or continued use of nicotine afterwards (both investigated and remarked on).

Nicotine was found to have no propensity for dependence in any studies.

The trials were conducted to evaluate nicotine therapy in cognitive dysfunction, degenerative and autoimmune illnesses where there had been indications that the alkaloid (typically present in the average diet) may provide benefit.

Ethics concerns are a crucial aspect of the discussion.

You’ll be able to see if you’re familiar with the realm of clinical trials, that there are a few key ethical concerns:

  • All clinical trials in the West are either approved or denied by ethics committees.
  • An ethics committee will not allow the study of any substance known or suspected to have the potential for addiction and/or harm.
  • All of these tests were done to evaluate nicotine on non-smokers and never-smokers, as the testing of smokers would have been pointless in such circumstances.
  • At every stage, every individual, including the ethical panels, recognised that heavy dosages of nicotine would be administered to non-smokers for months at a time.
  • It is unequivocally clear and beyond any doubt that the panel members and the physicians overseeing the studies knew that nicotine is risk-free and has no propensity for addiction – otherwise, all of them risked being charged with medical malpractice, sued for negligence, and kicked off if any of the dependence and harms ascribed to nicotine in the press were factual.
  • There will never be a trial where cocaine or another harmful or addiction-producing drug is given in high doses to innocent people for months at a time.
  • No one is going to propose a study to test it.
  • No one will be permitted to conduct such an experiment.
  • As a result, before the trials were proposed, people at all levels of the organisation understood that nicotine has no potential for addiction.

It is readily apparent that the private medical profile of nicotine and its public image are two separate things.

Why has a trial not been commissioned?

The anecdotal evidence on nicotine’s lack of dependence potential points to the result (all evidence demonstrates that nicotine has no reinforcement value outside of smoking). This might provide one answer as to why such research has not been published.

Many people would be delighted with a clinical study that addresses the effects of giving pure nicotine to non-smokers since this would answer several key queries.

Nonetheless, such a study will not see the light of day for numerous reasons.

  • The first problem is the taboos surrounding nicotine. However, this obstacle has been overcome many times before, as we have seen.
  • The serious problem of ‘rocking the boat’ needs to be addressed. This is a significant challenge – no medical expert wants to appear ignorant in front of their colleagues. And make no mistake: if such a trial, which solely aims to assess dependence, is allowed, many prominent individuals will look quite foolish.
  • Clinical trial funding generally comes from the pharmaceutical business, but because pharma is one of the leading forces propagating the notion that nicotine addiction is dangerous, funds are unlikely to be forthcoming.
  • Pharma has a significant stake in keeping control of nicotine, but anyone could possess a non-addictive, non-dependence-creating, and safe nutritional component.

An authorised study that produced the wrong conclusion would be buried; no prizes for guessing what would happen to a nicotine study that announced no potential for addiction outside of tobacco use.

However, considering the tremendous amount of attention paid to this issue, it is somewhat naive to believe such a trial has never occurred.

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